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Diagnosis • Technology • Therapy • Prevention APRIL/MAY 2014

The development of ferumoxytol-based MRI contrast agents may solve the issues with current whole body DW MRI in pediatric cancers

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CT and radiation exposure: is informed consent necessary?

Making Breast MRI available to more patients Esaote’s man at the top talks of his first year in charge Using elastography for prognosis in invasive breast cancer

Michelson Diagnostics focusses on Optical Coherence Tomography

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CAD in CT Colonography: good, but not for all polyps ­

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The value of mammography screening: here we go again

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ven nearly two years on, the shock waves from the bombshell publication from Bleyer and Welch regarding the true value of mammography screening show no sign of abating. If anything the breast cancer screening world is more confused than ever. As a reminder, in November 2012 Bleyer and Welch published in the highly prestigious journal The New England Journal of Medicine, their analysis of epidemiological data that had been gathered over three previous decades of screening mammography in the U.S. (Bleyer & Welch. Effect of three decades of screening mammography on breastcancer incidence, NEJM, 2012; 367: 1998). Their conclusion was that screening was having, at best, only a small effect on the rates of death from breast cancer. This finding was essentially based on their analysis that, despite substantial increases in the number of cases of early-stage breast cancer detected, mammography screening had only marginally reduced the rate at which women present with advanced cancer. The imbalance between these early and late stage cancer findings could, according to Bleyer and Welch only be explained by the fact that mammography screening was principally resulting in overdiagnosis (i.e. the detection of suspicious lesions which would not anyway have resulted in ultimately fatal cancers). The impact of the paper was amplified by its being picked up by the main-stream U.S. press, (who of course didn’t fail to add in the point about the dangers of the ionizing radiation involved in mammography) resulting in many women being confused and worried about whether mammography screening was actually causing them more harm than doing good. There was inevitably an outcry against Bleyer and Welch’s conclusions, with wild accusations about their findings being tantamount to condemning to death women who otherwise could have been saved by screening. Two year on, the debate for and against mammography screening is becoming even more vituperative, despite calls for less charged language and less extreme positions (Yaffe and Pritchard,

Overdiagnosing Overdiagnosis, The Oncologist 2014; 19; 103). The principal protagonist against Bleyer and Welch is Prof D Koppans, who doesn’t mince his words in his paper entitled “Arguments against Mammography Screening continue to be based on Faulty Science” (Koppans D. The Oncologist 2014 19; 107) and demands the withdrawal of the original Bleyer and Welch NEJM paper. In the time-honored tradition of academic polemics, Bleyer has just issued a rebuttal of such demands (Bleyer A. Were our estimates of overdiagnosis with mammography screening based on faulty science? The Oncologist 2014; 19:113) The minutiae of “for and against” arguments based on the interpretation of US-based epidemiological data can leave many non-statisticians, who include many European radiologists, glassyeyed. However any pretence that the debate was purely an academic American debate has now been dispelled with the publication of a report (Biller-Andorno & Jüni. Abolishing Mammography Screening Programs? A View from the Swiss Medical Board NEJM April 16 2014) from the Swiss Medical Board who, after an analysis of the levels of cancer detection versus overdiagnosis in mammography screening in Switzerland recommended that “no new systematic mammography screening programs should be introduced in Switzerland and that a time limit be placed on existing programs”. Although the recommendations of the Swiss Medical Board are not legally binding, the very fact that they raise the possibility of abolishing mammography screening entirely will surely have an impact — if only psychological — on many women who inevitably will wonder what to do. And while everybody agrees (one of the rare points of agreement in this heated debate) that the decision of whether to undergo mammography screening in the first place and, more importantly, what to do if a suspicious lesion is detected, is ultimately one for the woman in question to take, in full possession of the relevant facts, it is difficult to see how this is possible when even the statistical experts disagree so violently. n

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APRIL/MAY 2014

COVER STORY CAD in CT Colonography: CAD in CT colonography is more than just a future promise. CAD schemes increase the sensitivity of CT colonography by allowing the detection of more patients with only intermediate size polyps, without negatively affecting specificity.. By Dr D Regge ������������������������������������������������������������������������������������������������������������������ 12

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15| CT : is informed

consent necessary The discussion on the carcinogenic potential of radiation and the risk/benefits of radiological procedures such as CT shows no signs of abating. Will it end up with informed consent being needed for CT ?

26| Esaote’ s new man at the top talks of his first year in charge

With its high sensitivity, mri is the gold standard for breast imaging. A recent symposium reviewed the potential

The development of ferumoxytol-based MRI contrast agents may solve the issues with current whole body DW MRI in pediatric cancers

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Mean stiffness MEASURED BY ShearWave Elastography CORRELATES WITH HISTOLOGY IN iNVASIVE bREAST CANCER

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Imaging news First demonstration by MRI of the existence of brown adipose tissue in man.. . . 7-Tesla MRI shown to give more accurate diagnosis of breast cancer.. . . . . . DE-CT finds gout missed by traditional tests.. . . . . . . . . . . . . . . . . . . . Preoperative PET reduces pointless lung surgery in NSCLC.. . . . . . . . . . Study shows breast MRI increasingly used for screening high-risk women.. . .

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EU Study launched to analyze the effectiveness of cardiac CT over catheterization.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8 Ultrasound can identify pre eclampsia women at risk of respiratory failure. . . . . . 8 fMRI shows that “read“ and “heard” language processed differently by brain.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Michelson Diagnostics is focussed on the application of Optical Coherence Tomography in dermatology

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9 Obesity of mother means ultrasound can miss heart defects in fetuses.. . . . . . . 9 PET brain imaging could predict which vegetative patients have potential to recover consciousness.. . . . . . . . . . . . . . . . . . . . . .

10 Point-of-care ultrasound for suspected appendicitis in kids proves accurate.. . . . 10 Neuroimaging for headaches: high use and costs, despite guidelines.. . . . 11

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in the next issue: MSK Gastrointestinal CAD

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IMA GI N G NEWS First demonstration by MRI of the existence of brown adipose tissue in man

The first MRI scan to show ‘brown fat’ in a living adult could prove to be an essential step towards a new wave of therapies to aid the fight against diabetes and obesity. In a recently published report (Reddy et al, Identification of brown adipose tissue using MR imaging in a human adult with histological and immunohistochemical confirmation, J Clin Endocrinol Metab. 2014; 99: E117-21. doi: 10.1210/jc.2013-2036.), researchers from Warwick Medical School and University Hospitals Coventry and Warwickshire NHS Trust in the UK described the use of MRI to identify and confirm the presence of brown adipose tissue in a living adult. Brown fat has become a hot topic for scientists due to its ability to use energy and burn calories, helping to keep weight in check. Understanding brown fat tissue and how it can be used to such ends is of growing interest in the search to help people suffering from obesity or at a high risk of developing diabetes, as Dr Thomas Barber, from the Department of Metabolic and Vascular Health at Warwick Medical School, explained. The study showed the benefits of using MRI scans over the existing method, namely PET. Although PET can show brown fat activity, it is subject to a number of limitations including the challenge of signal variability from a changing environmental temperature. Unlike the PET data which only displays activity, the MRI can show brown fat content whether active or not – providing a detailed insight into where it can be found in the adult body. This information could prove vital in the creation of future therapies that seek to activate deposits of brown fat. Dr Barber added, “The MRI allows us to distinguish between the brown fat, and the more well-known white fat that people associate with weight gain, due to the different water-tofat ratio of the two tissue types. . http://tinyurl.com/BAT-paper

7-Tesla MRI shown to give more accurate diagnosis of breast cancer

Scientists at the MedUni Vienna have demonstrated for the first time that 7-Tesla ultra-high-field magnetic resonance imaging (MRI) can be used for clinical applications in patients with breast tumors and may in the future facilitate even more accurate diagnosis of breast cancer. The work has just been APRIL/MAY 2014

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published (Pinker et al. Clinical application of bilateral high temporal and spatial resolution dynamic contrast-enhanced magnetic resonance imaging of the breast at 7 T. Eur Radiol. 2014;24: 913). In previous studies involving 7-Tesla MRI, the exploration of clinical application had previously been limited to just one breast due to the limited coil technology available. “The new generation of coils allows clinical application on both sides,” explains Katja Pinker from the University Department of Radiology and Nuclear Medicine, Department of Molecular Imaging at the MedUni Vienna, who carried out the study in collaboration with the High Field MR Centre of Excellence and the Breast Health Centre at the MedUni Vienna and Vienna General Hospital. Pinker says that the 7-Tesla MRI scanner permits a high diagnostic accuracy of 96.6 per cent. The higher signal available with 7T permits a higher resolution, allowing fine details to be visualized better and a more certain diagnosis to be made. Diagnosis at molecular and metabolic level is also possible with diffusionweighted or sodium imaging and spectroscopy, so helping the characterization of tumors even more effectively.” The general outcome of the study was that bilateral ultrahigh-field MRI of the breast with 7-Tesla can be used clinically without problems, allowing more accurate diagnosis. “The future enhancement of ultra-high-field MRI of the breast with 7-Tesla using molecular and metabolic imaging could represent a further step towards personalized medicine, since not

every type of breast cancer is the same” added Pinker. By way of comparison, the current clinical standard MRI scans using a 3-Tesla device yield a diagnostic accuracy, with the very best equipment, of up to 93 per cent. The length of time of the investigation is also the same, whether it be a 3-Tesla or 7-Tesla scanner. The patient spends just over fifteen minutes in the tunnel. The clinical use of 7-Tesla in the examination of breast tumors is therefore possible immediately, however it also depends on the availability of suitable equipment: worldwide there are only eight university organizations that have a 7-Tesla device, including the one at the MedUni Vienna. http://tinyurl.com/Pinker-et-al-paper

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IMAGING NEWS

DE-CT finds gout missed by traditional tests

The incidence of gout is on the rise in the western world, and this very painful and most common form of inflammatory arthritis is turning out to be more complicated than had been thought. The standard way to check for gout is by drawing fluid or tissue from an affected joint and looking for uric acid crystals, That usually works, but not always: In a new Mayo Clinic study (Bongartz T et al Dual-energy CT for the diagnosis of gout: an accuracy and diagnostic yield study Ann Rheum Dis. 2014. doi: 10.1136) it was found that dual-energy CT scans found gout in one-third of patients whose aspirates tested negative for the disease.

The study tested the usefulness of DE CT scans in finding uric acid crystals around joints across a spectrum of gout and found that CT scans worked particularly well in detecting gout in patients who had experienced several gout-like flares but whose previous needle aspirates came back negative. After CT scans found what appeared to be uric acid crystals, ultrasound-guided aspirates were taken in those areas and tested for urate crystals. “These were in part patients that had been falsely diagnosed with diseases like rheumatoid arthritis or labeled with a different type of inflammatory arthritis, resulting in a completely different and often not effective treatment approach,” says first author Tim Bongartz, M.D., “And there were patients who remained undiagnosed for several years with, for example, chronic elbow symptoms or Achilles tendon systems, where the CT scan then helped us to pick up uric acid deposits.” Gout is often thought of as a man’s disease and associated with sudden sharp, burning pain in the big toe. It’s true that until middle age, more men than women get gout, but after the menopause, women catch up in the statistics. 6

And gout can hit more than the big toe: Other joints including parts of the feet, ankles, knees, fingers, wrists and elbows can also be affected. An accurate and early gout diagnosis is crucial because gout patients are treated with different medication than people with other forms of inflammatory arthriti. http://tinyurl.com/Bongartz-paper

Preoperative PET reduces pointless lung surgery in NSCLC According to recent research (Zeliadt S et al. Preoperative PET and the reduction of unnecessary surgery among newly diagnosed lung cancer patients in a community setting. J Nucl Med. 2014; 55: 379) 30 percent of surgeries performed for non-small cell lung cancer patients may be unnecessary. Positron emission tomography (PET) was found to reduce unnecessary surgeries by 50 percent. PET imaging prior to surgery helps stage a patient’s disease by providing functional images of tumors and metastases. Preliminary review of the data from this long-term, observational study of an entire community of veterans was inconclusive about the utility of PET, but after a more thorough statistical analysis accounting for selection bias and other confounding factors,

community that PET is very useful for identifying occult metastases and that it helps get the right people to surgery while avoiding unnecessary surgeries for those who would not benefit.” For this study, researchers reviewed newly diagnosed non-small lung cancer patients who received preoperative PET to assess the real-life effectiveness of PET as a preventative measure against unnecessarily invasive treatment across a community of patients. A total of 2,977 veterans who underwent PET during disease staging from 1997 to 2009 were included in the study. Of these, 976 patients underwent surgery to resect their lung cancer. During surgery or within 12 months of surgery, 30 percent of these patients were found to have advancedstage metastatic disease, indicating unnecessary surgery. Interestingly, the use of PET increased during the study period from 9% to 91%. Conventional multivariate analyses was followed by instrumental variable analyses to account for unobserved anomalies, such as when patients did not undergo PET when it would have been clinically recommended to do so. The new data have the potential to change policy and recommendations regarding the use of oncologic PET for more accurate tumor staging. http://tinyurl.com/Zeliadt-paper

Study shows breast MRI increasingly used for screening high-risk women

the researchers were able to conclude that PET imaging eliminated approximately half of unnecessary surgeries. “It has become standard of care for lung cancer patients to receive preoperative PET imaging,” said Dr Steven Zeliadt, lead author of the study . The prevailing evidence reinforces the general understanding within the medical D I

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Despite issues of expense, MRI is being increasingly used for breast cancer screening, diagnostic evaluation, treatment planning and surveillance but a recent study found that the indication for breast MRI APRIL/MAY 2014


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IMAGING NEWS has changed over time. Much of the increase was found among women with breast cancer risk factors, but there are still notable gaps in riskbased use. The study (Wernli KJ et al. Patterns of breast magnetic resonance imaging use in community practice. JAMA Intern Med. 2014;174:125) used data on breast MRI and mammography collected by five United States national Breast Cancer Surveillance Consortium registries from 2005 to 2009. The researchers calculated the rate of breast MRI examinations per 1000 women with breast imaging within the same year and described the clinical indications for the breast MRI examinations by year and age. They also compared women screened with breast MRI to women screened with mammography alone for patient characteristics and lifetime breast cancer risk. The study included 8,931 breast MRI examinations and 1,288,924 screening mammograms from women aged 18 to 79 years. Researchers found that in this period the overall rate of breast MRI nearly tripled. The most common clinical indication was diagnostic evaluation (40.3 percent), followed by screening (31 percent). Compared with women who received screening mammography alone, women who underwent screening breast MRI were more likely to be younger than 50 years, white non-Hispanic, and nulliparous and to have a personal history of breast cancer, a family history of breast cancer, and extremely dense breast tissue. Dr Tracy L. Onega, a co-author on the paper said “The benefit of breast MRI includes high sensitivity for identifying breast malignancy, and United States national guidelines support using it for particular clinical indications. But compared to mammography, breast MRI is more expensive and can lead to higher false positive rates. We need to continue to evaluate and compare the effectiveness of how MRI and mammography are used and find ‘the right test for the right woman at the right time’. The findings of our study suggest the continued need for evidence that will help align use of breast MRI” http://tinyurl.com/Wernli-et-al-paper 8

EU Study launched to analyze the effectiveness of cardiac CT over catheterization Scientists from 28 research facilities in 20 European countries met earlier this year to kick off the collaborative EU research project known as DISCHARGE, whose purpose is to determine for which patients with chest pain would cardiac CT be best indicated as opposed to cardiac catheterization.

Coronary artery disease (CAD) is the leading cause of death in high-income countries. Invasive coronary angiography (ICA) is the reference standard for the diagnosis of CAD and allows immediate therapy. However, only 40% of patients undergoing ICA actually have obstructive CAD and ICA has relatively rare but considerable risks. Coronary computed tomography (CT) is the most accurate diagnostic test for CAD currently available. CT may become the most effective strategy to reduce the approximately 2 million annual negative ICAs in Europe by enabling early and safe discharge of the majority of patients with an intermediate risk of CAD. To evaluate this, the DISCHARGE project has been set up, to be carried out by a multinational European consortium. The core of the project is a pragmatic randomized controlled trial. The primary hypothesis will be that CT is superior to ICA for major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and stroke) after a maximum follow-up of 4 years in a selected broad populaD I

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tion of stable chest pain patients with intermediate pretest likelihood of CAD. The trial will include 23 clinical sites from 18 European countries, thus ensuring broad geographical representation. Comparative effectiveness research of complementing work packages include genderrelated analysis, systematic review of evidence, cost-effectiveness analysis, and health-related quality of life. DISCHARGE has the capability to influence current standards and guidelines as well as coverage decisions and will raise awareness among patients, health care providers and decision-makers in Europe about the effectiveness and cost-effectiveness of coronary CT angiography. The DISCHARGE project received six million Euros of funding from the European Union for five years and is coordinated by Charité – Universitätsmedizin Berlin under the leadership of Prof. Marc Dewey of the Department of Radiology at the Charité hospital in Berlin. “Given the broad scope of our DISCHARGE collaborative research, we expect to achieve conclusive results, which will directly impact practice in cardiovascular medicine. We very much hope that our findings can contribute to improving medical care for cardiac patients”, commented Prof. Dewey at the start of the project. http://tinyurl.com/Project-pageCharite

Ultrasound can identify pre eclampsia women at risk of respiratory failure An ultrasound examination of the lungs could help to determine if a pregnant woman with preeclampsia is at risk of respiratory failure, suggests preliminary research from a group of clinical researchers based in Marseilles, France (Zieleskiewicz L et al. Lung ultrasound predicts interstitial syndrome and hemodynamic profile in patients with severe preeclampsia. Anesthesiology. 2014;120: 906). About 60,000 women worldwide die as a result of preeclampsia, which causes severely high blood pressure. Potential complications include stroke, bleeding and pulmonary edema, which can lead APRIL/MAY 2014


IMAGING NEWS to respiratory failure. The French study suggested a lung ultrasound could indicate whether a woman with preeclampsia is suffering from pulmonary edema and ensure she receives the correct treatment. “Lung Ultrasound is fast, safe, noninvasive and easy to use” said Dr M Leone. “We found it allowed us to quickly assess whether a woman with preeclampsia had pulmonary edema and confirm the severity of the condition.” In the study, the researchers performed both cardiac and lung ultrasounds before and after delivery in 20 women with severe preeclampsia. Five of the 20 women had pulmonary edema prior to delivery according to lung ultrasound, while four had the condition according to the cardiac ultrasound. Thus, the lung ultrasound identified a patient with non-cardiac pulmonary edema, which the cardiac ultrasound did not detect. The test results could help ensure that pregnant women with pulmonary edema not be given intravenous or excess fluids, which worsens the condition and can lead to respiratory failure. Urine output is often measured to determine if a woman needs fluid administration, but the results are wrong about half of the time. “Lung ultrasound enables the medical team to identify which women really need the fluid treatment” noted Dr. Zieleskiewicz, the study’s first author. http://tinyurl.com/Zieleskiewicz-paper

fMRI shows that “read“ and “heard” language processed differently by brain The brain processes “read” and “heard“ language differently. This is the key and new finding of a study carried out at the University Department of Radiology and Nuclear Medicine at the MedUni Vienna (Kollndorfer K et al. Attention shifts the language network reflecting paradigm presentation. Frontiers in Human Neuroscience, 2013; 7 DOI 10.3389 ). The researchers were able to determine the affected areas of the brain using speech processing tests with the aid of functional magnetic resonance tomography (fMRT). In the study, the healthy test subjects were played simple nouns via headphones or shown them on a screen. They then had to form matching verbs from them. Says Kolindorfer: “Depending on whether the words were heard or seen, the neurons fired at different locations in the network.” The results of the study also offer the field of radiology new opportunities for the pre-operative determination of areas that need to be protected during neurosurgical proceAPRIL/MAY 2014

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dures -- for example the removal of brain tumors -- in order to maintain certain abilities. With regard to the speech processing parts of the brain in particular, individual mapping is especially important since individuals differ in terms of the location of their speech processing centres. “This also gives radiologists a tool with which they can decide whether it makes more sense during testing to present the words in visual or audible form” said Kathrin Kolindorfer lead researcher . “Our results therefore show that the precise and personalized planning of radiological investigations is of tremendous importance,” says the author. Following this investigation, the best proposed solution is then drawn up within the multidisciplinary team meetings with the patient. http://tinyurl.com/Med-Univ-Vienna

Obesity of mother means ultrasound can miss heart defects in fetuses

Each year in Europe thousands of children are born with serious malformations, of which almost half are heart defects. Discovering these during the first stage of pregnancy is a major challenge for prenatal healthcare. “The lives of children born with serious heart defects are in constant danger; some of them need immediate operations or medical treatment. If these defects are detected during the pregnancy, the babies can be born in hospitals that have facilities for child heart surgery” explains Eric Hildebrand, senior physician at the Linköping University Hospital Women’s Clinic. But more than six out of every ten serious heart defects in fetuses go undetected in the ultrasound scans given to all pregnant women. According to research recently carried out at Linköping University in Sweden, one reason why malformations are not found is obesity in the expectant mother.

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IMAGING NEWS The Swedish group carried out a study involving the examination of over 21,000 ultrasound scans in the southeast healthcare region in Sweden, covering the counties of Jönköping, Kalmar and Östergötland. In this region all expectant mothers are offered two ultrasound scans, the first at weeks 11-14, and the second at weeks 18-20. In the first scan the midwife dates the pregnancy, looks for the possibility of twins and carries out a general examination of the anatomy of the embryo. In the second scan the organs are screened for malformations. In the study the results of the two scans were compared. Not surprisingly, considerably fewer malformations are detected in the first scan. It was particularly difficult to find heart defects. During the eleventh to the fourteenth weeks no defects at all were found but in the eighteenth to twentieth week, 37% of serious defects were discovered. One reason for missing malformations is that the ultrasound image is affected by the body of the mother. For example diagnosis is made more difficult by obesity–a BMI over 30–which was the case in 13% of the mothers. “Subcutaneous fat detracts from the quality of the image, making it more difficult for us to see malformations” says Dr Hildebrand who suggests two important measures: •The methods of detecting heart defects need to be improved. One way is to give midwives additional education and training in interpreting heart images, including color Doppler for blood flow in the heart. •The best diagnostic tool for Downs Syndrome is the CUB (Combined Ultrasound and Biochemical screening test), which works just as well regardless of whether the mother is obese or not. http://tinyurl.com/Linkoping-Univ

PET brain imaging could predict which vegetative patients have potential to recover consciousness According to new research from Liège, Belgium and published in The Lancet ( Stender J et al Diagnostic precision of PET imaging and functional MRI The Lancet April 16th 2014) functional brain imaging using PET is a promising tool for determining which severely brain damaged individuals in vegetative states have the potential to recover consciousness In severely brain-damaged individuals, judging the level of consciousness is challenging. Traditionally, bedside clinical examinations have been used to decide whether 10

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patients are in a minimally conscious state (MCS), in which there is some evidence of awareness and response to stimuli, or are in a vegetative state (VS), where there is neither, and the chance of recovery is much lower. But up to 40% of patients are misdiagnosed using these examinations. The new study assessed whether two functional brain imaging techniques— FDG-PET and fMRI could distinguish between vegetative and MCS in 126 patients with severe brain injury (81 in a MCS, 41 in a VS, and four with locked-in syndrome—a behaviorally unresponsive but conscious control group) who had been referred to the University Hospital of Liége, from across Europe. The researchers then compared their results with the wellestablished standardised Coma Recovery Scale–Revised (CSR-R) behavioral test, which is considered the most validated and sensitive method for discriminating very low awareness. Overall, FDG-PET was better than fMRI in distinguishing conscious from unconscious patients. Mental imagery fMRI was less sensitive at diagnosis of a MCS than FDGPET, and had less agreement with behavioral CRS-R scores than FDG-PET. Likewise, FDG-PET was about 74% accurate in predicting the extent of recovery within the next year, compared with 56% for fMRI. Importantly, a third of the 36 patients diagnosed as behaviorally unresponsive on the CSR-R test who were scanned with FDG-PET showed brain activity consistent with the presence of some consciousness. Nine patients in this group subsequently recovered a reasonable level of consciousness. “Our findings suggest that PET imaging can reveal cognitive processes that aren’t visible through traditional bedside tests and could substantially complement standard behavioral assessments to identify unresponsive or “vegetative” patients who have the potential for long-term recovery”, says study leader Professor Steven Laureys. Commenting on the study, Jamie Sleigh and Catherine Warnaby add, “From these data, it would be hard to sustain a confident diagnosis of unresponsive wakefulness syndrome solely on behavioral grounds, without PET imaging for confirmation. Functional brain imaging is expensive and technically challenging but it will almost certainly become cheaper and easier. In the future, we will probably look back in amazement at how we were ever able to practise without it.” http://tinyurl.com/Stender-et-al

Point-of-care ultrasound for suspected appendicitis in kids proves accurate Using portable ultrasound as a first-line imaging study in kids with suspected appendicitis helps reduce emergency room length of stay and reduces the need for CT scans, according to a recent study (Elikashvili et al.

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IMAGING NEWS The Effect of Point-of-care Ultrasonography on Emergency Department Length of Stay and Computed Tomography Utilization in Children With Suspected Appendicitis. Acad Emerg Med. 2014;21:163) In the study, investigators looked at the records of 150 children seen consecutively between May 1, 2011 and October 1, 2012 in an urban pediatric emergency department. All children were under evaluation for suspected appendicitis. Outcomes were determined by surgical or pathology report in those found to have appendicitis and three weeks later in patients who were deemed not to have appendicitis. The time to perform the point-of-care ultrasound and CT scan use was measured. “CT scans have been the best imaging test for diagnosing appendicitis, but they expose children to radiation, which cumulatively can prove harmful” said the study’s senior author, Dr J W Tsung “CT scanning rate was reduced by over 35% during the study,” commented Dr Ee Tay, the study’s second author. The study showed that emergency department length of stay declined by 2 hrs and 14 minutes (46% decrease) for those requiring radiology department ultrasound and nearly 6 hours (68% decrease) for those requiring CT scan when point-of-care ultrasound was inconclusive as a firstline imaging study. Importantly, no cases of appendicitis were missed with the point-of-care ultrasound protocol and no unnecessary surgeries were performed for a normal appendix. http://tinyurl.com/Elikashvili-et-al

Neuroimaging for headaches: high use and costs, despite guidelines.

Alhough guidelines discourage MRI and CT use for routine headache and migraine, 12 percent of visits to a doctor for headaches result in a scan according to a recent study from University of Michigan Medical School (Callaghan BC et al Headaches and Neuroimaging: High Utilization and Costs Despite Guidelines. JAMA Intern Med. 2014 Mar 17. doi: 10.1001). The study used United States national data on headache-related doctor visits and neuroimaging scans on people over age 18 and calculated total costs involved. In all, 51.1 million headache-related patient visits occurred between 2007 and 2010 – nearly half of them related to migraine. The vast majority were by people under the age of 65, and more than three-quarters of the patients were women. In those same four years, 12.4 percent of these visits resulted in a brain MRI or CT, at a total cost of about $1 billion a year. In fact, in the United States, several national guidelines for doctors specifically discourage scanning the brains APRIL/MAY 2014

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of patients who complain of headache and migraine. But the new study shows the rate of brain scans for headache has risen, not fallen, since guidelines for doctors came out. But past research shows that only 1 percent to 3 percent of scans of patients with repeated headaches find that a growth or blood vessel problem in the brain is to blame. “Lots of guidelines say we shouldn’t do this – including ones from neurology and radiology groups ” says Dr Brian Callaghan, the neurologist who led the study. “In fact, the number of times that serious issues are found in scans in headache patients is about the same as that for a randomly chosen group of non-headache patients” he says. But the fact that 14.7 percent of people who saw a doctor for headache or migraine in 2010 went on to have a brain scan would not be expected if guidelines were being followed, he added. http://tinyurl.com/Callaghan-et-al-paper

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CAD By Dr D Regge

Computer Aided Diagnosis in CT Colonography: good but not for all polyps

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omputer-aided diagnosis (CAD) systems are software algorithms designed to assist radiologists in solving a diagnostic problem by using a visual prompt (or “CAD mark”) to direct the observer towards potential pathological lesions. Such algorithms can either be used to help pinpoint areas of disease or to help interpreters decide the nature of abnormal findings. Regardless of the precise role in which CAD is used, the final diagnostic decision must always be made by the human interpreter, who decides whether or not to “believe” and accept the CAD marks.

CAD in CT colonography

This is attractive for two main reasons. Firstly, compared to lung and breast, where a spectrum of benign and malignant lesions may be present, the colon model is very straightforward. The vast majority of colon findings are polyps; cancer and other types of lesions are rare. Such a dichotomous situation, where two opposing choices are available, namely either normal tissue or polyp, is ideal for CAD systems. Secondly, we know that half to three-quarters of lesions missed by the radiologist are caused by “perceptive errors”, meaning that the lesions could have been detected. The rate of occurrence of perceptive error is affected by several factors. These include reader experience, intrinsic diagnostic threshold, the quality of the exam, the nature of the working environment and finally the lesion characteristics and morphology. CAD could increase the polyp detection rate and could hopefully also speed up reading, especially in those situations where disease prevalence is expected to be low, such as in the average risk individual. Several retrospective studies have compared unassisted interpretation with CAD-assisted reading in polyp enriched populations. Typically, the design of such trials consists in having multiple readers review sets of CTC cases in a laboratory environment. The exam is interpreted twice, once with the aid of CAD. Readings are carried out a few weeks apart to avoid recall bias. CAD has been tested in many studies, either as a first reader, as a second reader or in simultaneous or concurrent reading. It is beyond the scope of this review to give The Author Daniele Regge M.D., Chief of the Radiology Unit Istituto di Candiolo-IRCCS, Turin, Italy, E-mail daniele.regge@ircc.it

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Dr D. Regge is head of Radiology in the Istituto di Candiolo-IRCCS, Turin, Italy.

the details of the results of all these studies. Suffice it to say that CAD has been shown to be more accurate when used as a second reader — i.e. after a fully unassisted interpretation — as it increases CTC sensitivity, at the price of a small reduction in test specificity. Recently a multireader, multicase trial [4] using ROC analysis demonstrated an overall benefit of CAD with respect to unassisted interpretation (per segment AUC of 0.758 vs 0.737; p<0.015). However, the retrospective nature of these studies does not guarantee that the results will be reproducible in dayto-day practice. Also, the application of this model to low prevalence populations could yield different results. Prospective trial design

To overcome these limitations, we designed a prospective trial to assess the effect on sensitivity and specificity of the use of CAD as a second reader. The study was powered to detect a difference in the sensitivity of intermediate size polyps, i.e. those between 6 and 9 mm. As the expected disease prevalence of such lesions was estimated to be around 10%, it was calculated that a sample size of at least 600 individuals would be needed. Ten Italian imaging centers participated in the study, with each center recruiting from 9 to a maximum of 285 participants. All centers were equipped with the same workstation (im3D, Torino, Italy) that was customized for the study. Readers were all experienced and, before beginning the study attended a 2 day course to learn how to use the specialized software. The workflow was as follows: Individuals performed full bowel cleansing. In addition, three of the ten centers, dealing with about 60% of the total number of cases, used a fecal tagging protocol. Patients underwent CTC in the morning and were then sent to the endoscopy unit for conventional colonoscopy which was performed, on average, 3 hours after CTC. In the meantime the radiologist carried out — unassisted — a full review of the imaging study, using a primary 2D paradigm and endoluminal 3D for problem solving. All lesions were marked manually, and the size and position of lesions were reported. In the second stage the radiologist activated the CAD algorithm and reviewed the two lists of CAD prompts generated from the supine and prone scans respectively. All additional findings were also recorded as above. CTC interpretation was performed in a clinical environment, during a regular reporting session within 3 hours from completion of the test. Information from the CT findings were then reported segment by segment to the endoscopist to check for possible false negative findings of colonoscopy.

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(CI:87.6%, 97.8%). No significant change in specificity was observed when CAD was added to CT colonography interpretation. CAD-assisted reading allowed the identification of 10 additional polyps, including 9 adenomas in the 6-9 mm range. Interestingly, if all CAD prompts had been properly accounted for, CADassisted reading would have reported 11 additional 6-9 mm polyps and 6 additional >9 mm lesions [See Figures]. Al 22 cancers were correctly detected by CT colonography. Finally the median reading time was increased from 6.5 to 8.1 minutes with the use of CAD. Discussion

Example of a polyp correctly prompted by CAD but rejected by the radiologist. A) The axial CT scan shows a 6 mm peduncolated polyp of the transverse colon. B-C) The lesion is correctly identified by CAD as shown on both the axial 2D image (yellow-box) and on the 3D endoluminal view (red colour). D) The polyp was removed at colonoscopy performed on the same day of CT colonography. The radiologist was probably misled by the large number of untagged fecal residues having the same gross shape and size as the polyp.

Results

Of the 651 individuals enrolled in the study 33 were excluded, mainly for refusal to accept either CT colonography and/ or colonoscopy, leaving a final population of 618. It was found that the improvement of CTC performance was related to lesion size. Sensitivity improved significantly for patients with only intermediate size polyps (from 65.4% to 76.9%; 95% CI:63.2%, 87.5%; P< 0.016) while the sensitivity of unassisted reading and CADassisted reading for patients with large lesions only (> 9 mm) were both 94.1%

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This is the first study that was able to demonstrate the beneficial effect of CADassisted CT colonography in a clinical setting. It is also significant that all the additional 6 to 9 mm polyps were adenomas, the majority with an advanced histology. In this series approximately one third of polyps were advanced adenomas, which are lesions that have a higher malignant potential. Conversely, the fact that the results of unassisted and CAD-assisted reading were equivalent for the detection of large polyps is not surprising. The high reader sensitivity of CT-colonography for large lesions is well documented. Reading time is an additional important factor to consider, especially in a screening scenario, where a large work-load of exams needs to be reported in the shortest possible time. Reducing reporting time while keeping high quality standards will limit costs and allow skilled radiologists to increase their throughput. In this trial CAD-assisted reading extended reporting time by 1.6 minutes. However, a gain of 12 minutes was noted in reporting time when comparing these results to those of a previous trial, which largely used the same readers reporting solely unassisted. While this may be due to the use of better, more powerful software in the most recent trial, we also believe that human-CAD interactions may affect the whole reading process positively. We have observed that the more the readers trust their CAD system, the less time they spend reading unassisted. But obviously this will happen only if the CAD scheme they use has a sufficiently high stand-alone performance. D I

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Research is being undertaken to further understand the interactions between radiologist and CAD schemes. Recently we proposed an alternative double reading paradigm where CAD is the first reader and where the radiologist rapidly reviews the 2D datasets to search for large infiltrating or flat lesions that might have been missed by CAD. Preliminary results demonstrate that the “double reader, CAD first reader model” is more timeefficient than the second reader model and has equivalent accuracy. We have therefore decided to use the “double reading first reader CAD” model in a large randomized CT colonography screening trial, which will recruit nearly 3000 individuals only in the imaging arm. Other groups have used computer-generated CAD image galleries to increase reading efficiency, without decreasing detection of clinically significant colorectal lesions [5] Conclusion

CAD in CT colonography is more than just a future promise. CAD schemes increase the sensitivity of CT colonography by allowing the detection of more patients with only intermediate size polyps, without negatively affecting specificity. In addition, overall reading time is reduced. A better understanding of human-CAD interactions should allow determination of the most appropriate CAD algorithm in specific clinical situations and how reporting is affected by reader experience. Hopefully, answers to these aspects will be revealed when the results of ongoing screening trials are available. References A complete bibliography is available from the author. 1: Regge D et al. Efficacy of computer-aided detection as a second reader for 6-9-mm lesions at CT colonography: multicenter prospective trial. Radiology. 2013; 266:168. 2: Iussich G et al. CT colonography: preliminary assessment of a double-read paradigm that uses computeraided detection as the first reader. Radiology. 2013; 268: 743 3: Regge D, Halligan S. CAD: how it works, how to use it, performance. Eur J Radiol. 2013; 82: 171 4: Dachman AH et al. Effect of computer-aideddetection for CT colonography in a multireader, multicase trial. Radiology. 2010 ; 256: 827. . 5: Mang T et al. Time-efficient CT colonography interpretation using an advanced image-gallerybased, computer-aided “first-reader” workflow for the detection of colorectal adenomas. Eur Radiol. 2012; 22: 2768

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Radiation exposure By Dr L. Berlin

CT, Radiation exposure and Carcinogenesis: is informed consent necessary? The discussion on the carcinogenic potential of radiation and the risk/benefits of radiological procedures such as CT shows no signs of abating. This article summarizes the background to the issues, puts the arguments into perspective and describes the radiologist’s duty and obligations in the midst of an increasingly heated debate

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t was not many years after Roentgen’s discovery of the X-ray in 1895 that scientists began recognizing that exposure to ionizing radiation caused cancer. The first case of radiationinduced cancer was documented in 1902 [1], and over the next several decades there occurred sporadic cases of skin cancer among physicists and radiologists who worked with radiation sources. Exposure to radiation was the presumed cause of aplastic anemia that was fatal to Marie Curie; of lung cancers that were fatal to pitchblende and uranium miners, and of the bone cancers that were fatal to radium-dial watch workers who licked brushes coated with radium [1-2]. Nevertheless, the concept of radiation-induced cancer attracted little concern in the scientific community, and the public’s awareness of the potential adverse effects of radiation was minimal if even existent — until August, 1945, when the atomic bombings of Hiroshima and Nagasaki took place. The incidence and natural history of cancers that developed among the survivors of the atomic bombings provided an enormous amount of epidemiologic data from myriad studies analyzing the relationship between radiation exposure and cancer, many of which are still ongoing. Although there was a plethora of research studies focusing on the carcinogenic properties of ionizing radiation that appeared in scientific journals following World War II, the subject did not generate much public attention. However, the public’s awareness and concern with radiationinduced cancer were noticeably raised as a result of the Chernobyl nuclear reactor accident in 1986 in the Soviet Union, and increased more so as a result of the Three-Mile-Island nuclear The Author Leonard Berlin, M.D., F.A.C.R., is at Radiology Department, Skokie Hospital, Skokie, Illinois, USA. and is Professor of Radiology, Rush University, Chicago, Illinois, USA. & University of Illinois, Chicago, Illinois, USA. Correspondence to: Leonard Berlin, M.D., F.A.C.R. Skokie Hospital, 9600 Gross Point Road, Skokie, IL 60076, USA E-mail: lberlin@live.com

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reactor accident in 2001 in the state of Pennsylvania, USA. It was not until 2007, however, that the carcinogenic properties of radiation made headlines on television news broadcasts and front pages of America’s newspapers. “Overuse Of Diagnostic CT Scans May Cause 3 Million Excess Cancers In USA Over Next 2-3 Decades,” was the front-page headline of US Today [3], a nationally circulating American newspaper, in November 2007. The headline in part was based on a New England Journal of Medicine (NEJM) article in which two prominent radiation physicists pointed out that atomic bomb survivors who had received radiation doses in the range of 5 to 150 milliSieverts (mSv) — similar to the dose received from patients undergoing various CT scans — showed significant increase in cancer occurrence. They then estimated that up to “2% of all cancers in the US may be attributable to the radiation from CT studies” [4]. Over the next several years, a number of scientific articles made the front-page headlines. “29,000 future cancers could be related to CT scan use in the US in 2007….There is direct evidence from atomic bomb survivors, nuclear workers, and patients receiving X-ray exams that radiation doses of 5-10 rads (50-100 mSvs) can cause cancer,” exclaimed a group of epidemiologist [5]. One Chicago newspaper published an article on the topic under a headline that read, “Two or Three CT Scans = Hiroshima Radiation” [6]. Notwithstanding reports emphasizing that diagnostic level doses of ionizing radiation cause cancer, many radiation physicists strongly disagreed, several asserting, “Cancers have never been detected in animals or in humans for doses below 100 mSv” [7]. A review of the scientific literature on the subject of radiationinduced cancer clearly reveals the contradictory findings and conclusions of a divided community of radiation physicists. Although all agree that radiation-induced carcinogenesis increases with high doses, whether there is a threshold dose required to generate a cancer is extremely controversial. A large segment of the radiation physicist community subscribes to the linear no-threshold theory, i.e., there is no threshold and even the most minimal exposure to ionizing radiation is carcinogenic. An equally large segment of the radiation physicist community has adopted a contrary opinion, namely, that there is a threshold below which

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Radiation exposure

radiation exposure will not cause cancer. Nevertheless, there is almost unanimous agreement that there is a risk of carcinogenesis from doses greater 100 mSv. Public concerns regarding carcinogenic effects of radiation exposure were heightened substantially in March 2011 when a tsunami virtually destroyed the Fukushima Daiichi Nuclear Power Plant in Japan [8]. The extent to which workers and residents living in the vicinity of Fukushima will develop cancer as a result of exposure to the radiation that was released by the power plant remains to be determined. Informed Consent

A century ago, an American jurist enunciated a fundamental principle in medicine: “Any human being of adult years and sound mind has a right to determine what should be done with his own body” [9]. “The doctrine of informed consent is one of the most well-known elements of medical ethics and bioethics today and is a pivotal principle that guides contemporary healthcare and research practices,” states the International Bioethics Committee of UNESCO [10]. Informed consent is required for all patients who are about to undergo a radiologic examination or procedure that is not considered simple. What kind of information should be communicated to the patient in order for the patient to decide whether to consent? One American state supreme court answered the question in this manner: “Information regarding risk is material when a reasonable person would be likely to attach significance to it in deciding whether or not to forego the proposed examination or treatment…. The standard to which a physician is held is determined by whether a reasonable person in the patient’s position would have arrived at a different decision about the treatment or examination had he or she been fully informed” [11]. The UNESCO Bioethics Committee added the following clarification: “In general, adequate information given to the patient is the condition sine qua non for consent to be validly obtained….Information must be adequate and comprehensible”[10]. An American College of Radiology (ACR) Practice Guideline adds that informed consent must be obtained prior to any procedure or examination “that is likely to expose the patient to any significant risks and potential complications” [12]. Defining the words “risk” and “significant” is not so simple, particularly as the words apply to exposure to radiation and potential development of cancer. If a patient is going to undergo a procedure such as a thoracentesis, arteriogram, angioplasty, biopsy, or is to be administered contrast media, it is a relatively simple exercise to consult the radiologic literature and apprise oneself of the statistical likelihood that a complication such as a pneumothorax, hemorrhage, thrombosis, or anaphylactic reaction can occur. While no physician is able to predict with certainty whether a complication will or will not occur after a specific procedure, nonetheless the physician can be exact regarding the odds that a given complication may occur. However, with regard to the exact likelihood that a cancer can develop as a result of exposure to diagnostic level radiation, no available statistical data are available. 16

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The medical literature is replete with hypotheses, conjectures, projections, extrapolations, and opinions, but not hard facts. The literature is full of theoretical calculations regarding risk, rather than the documented incidence of risk. For example, an article in one medical journal stated, “Lifetime cancer risk due to radiation from a single coronary artery calcium score CT scan at age 40 is 9 cancers per 100,000 in men, and 28 cancers per 100,000 in women” [13]. How can we possibly relate this theoretical “projection” to the likelihood of a single patient developing cancer by undergoing a coronary CT scan? Another journal article reported that in a study of 180,000 patients younger than age 22 who had undergone approximately 280,000 CT scans in the United Kingdom between 1985 and 2002, 72 developed leukemia and 135 developed a brain tumor [14]. The researchers estimated that one head CT scan performed in the first decade of life would produce one case of leukemia and one case of brain tumor per 10,000 patients who underwent CT. How does this kind of “information” qualify as accurate and comprehensive data that will assist a patient in making a decision whether to consent or not consent to a procedure? As an analogy, a quick search of public data reveals that in the year 2011, a total of approximately 33,000 people in the US died as a result of a motor vehicle accident [15]; in other words, with an approximate population of 330 million, there was about one death per 10,000, similar to the number of children who theoretically “may” develop leukemia or brain tumor as a result of undergoing a CT scan. The automobile data are based on facts: one person in 10,000 actually died in an auto accident. The CT data, however, are projections: the leukemia or brain tumor that may occur in one child per 10,000 may, or may not, have been caused by exposure to CT scan radiation. I cannot conceive of anyone advocating informing an individual who was about to enter a motor vehicle that his or her chances of dying in an accident is 1 in 10,000. Should parents who are being advised by a physician that their child should undergo a CT scan be informed that the chances of the child developing leukemia or brain tumor is 1 in 10,000? Should a man being advised to undergo a coronary CT be informed that his chance of developing cancer is 1 in 10,000 [13]? Carcinogenesis from Diagnostic Level Ionizing Radiation Remains Nebulous

The United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) pointed out, “There is still uncertainty about the best method for transferring organ-specific cancer risks from the Japanese A-bomb survivors to populations in other countries with differing baseline rates….The ability of epidemiological studies to detect raised cancer risks at very low doses is constrained not only by limitations on statistical power but also by the potential for small biases or confounding” [16]. As recently as December 2013, UNSCEAR called on its Scientific Committee “to hold regular sessions on an annual basis so that its report can reflect the latest developments and findings

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in the field of ionizing radiation…and understanding of the levels, effects, and risks of ionizing radiation” [17]. A recently published report contended that reevaluation of atomic bomb survivor data showed lower than expected cancer rates, and thus there is “no longer any credible reason to support the claims of increased risk of cancer from low-dose radiation” [18]. The author researcher added that considerable evidence has accumulated suggesting a beneficial effect of low-dose radiation (hormesis), including reduction of cancer. Another researcher echoed similar sentiments, stating that “Nuclear fears simply don’t match the facts” [19]. The Radiologists’ Duty

From a historic and traditional viewpoint, the duty of the referring physician was to order the radiologic examination, and the sole duty of the radiologist was to render his or her interpretation of this exam. However, the 21st century brought many changes, among which is expansion of radiologists’ duties. It has been estimated that medical imaging is responsible for approximately 50% of the average radiation exposure in the US population, with half of all medical radiation coming from CT scans [20]; cardiologic imaging is responsible for 40% [21]. Radiologists are no longer considered simply as bystanders when a radiologic exam is ordered and performed; today radiologists are expected to review requests for radiologic exams and in the interest of reducing costs and exposure to ionizing radiation, intervene when a request is deemed incorrect or unnecessary. In most cases, there is no reason for the radiologist to question the judgment of a referring physician; the medical indication for the exam is valid, and the appropriate exam is ordered. However, if the radiologist has the patient’s previous studies available and notes that in the recent past the patient had undergone several similar CTs, it may well be the radiologist’s duty to contact the ordering physician, pointing out that multiple similar exams that had been performed in recent months, and suggesting that either an alternate imaging study free of ionizing radiation be ordered, or simply that the requested study be cancelled.

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The standard of care today does not require that formal informed consent be obtained from patients before they undergo imaging exams utilizing ionizing radiation [22]. Nevertheless, over the past several decades the relationship between patients and their physicians has shifted from benevolent paternalism (“I, the doctor, possess knowledge and I will decide what tests you, the patient, must undergo”) to shared decision making (“I, the doctor, will share my knowledge including benefits and harms of all tests with you, the patient, and you will decide whether to undergo the test”) [23]. Radiologists are physicians, and therefore it is their moral, if not legal, responsibility to be adequately educated and knowledgeable [24] about radiation doses, to review requests involving high-dose studies, and to discuss uncertainties regarding the potential hazards of radiologic imaging, including but not limited to carcinogenesis, with clinicians and patients when either asked to do so or when the radiologist believes it will benefit the welfare of the patient to do so. Radiologists should also become familiar with and embrace the Image Wisely for Adults, Image Gently for Children, and ALARA (image As Low as Reasonably Achievable) Campaigns [25-26]. References: 1. Prasad KN. Handbook of radiology. 2nd ed. Boca Raton, FL. CRC Press, 1984;1-4 2. Hall EJ. Radiology for the radiologist. Second Ed. Hagerstown, MD. Harper and Rowe 1978;362 3. USA Today, November 29, 2007 4. Brenner DJ, Hall EJ. Computed tomography – an increasing source of radiation exposure. NEJM 2007; 357: 2277 5. deGonzalez AB et al. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med 2009; 2071 6. Chicago Tribune, Sec. 1, pg. 16. January 7, 2011 7. Tubiana M, et al. The linear no-threshold relationship is inconsistent with radiation biologic and experimental data. Radiology 2009;251:13 8. Muller R. The panic over Fukushima. Wall Street Journal, August 18-19, 2012:C1-C2 9. Schloendorff v The Society of New York Hosp. 105 NE 92 (NY 1914) 10. Report of the International Bioethics Committee of UNESCO (IBC): ON CONSENT. Introductory Remarks, Page 7. Accessed 4-7-2014 Available at: http://ec.europa.eu/energy/nuclear/radiation_protection/doc/publication/125.pdf 11. Johnson v Kokemoor, 545 NW 2d495 (WI 1996) 12. American College of Radiology, Society for Interventional Radiology. ACR-SIR practice guideline on informed consent for image-guided procedures. Accessed: 4/11/2014 Availabe at: http:// www.sirweb.org/clinical/cpg/Informed_consent_Final7109Ed01.pdf 13. Ioannidis JPA, Tzoulaki I. What makes a good predictor? The evidence applied to coronary artery calcium score. JAMA 2010;303:1646-1647 14. Pearse MS et al. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. The Lancet. 2012;380: 499 15. List of motor vehicle deaths in U.S. by year. Wikipedia Free Internet Encyclopedia. Accessed 4-72014 Available at: http://en.wikipedia.org/wiki/List_of_motor_vehicle_deaths_in_U.S._by_year 16. Low dose ionizing radiation and cancer risk. United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) Proceedings of Scientific Seminar, Luxembourg, November 2, 2000;69 Accessed 4-7-2014 Available at: http://ec.europa.eu/energy/nuclear/radiation_protection/doc/publication/125.pdf 17. United Nations Resolution adopted by the General Assembly on 11 December 2013: 68/73 Effects of atomic radiation. Accessed 4-7-2014, Available at: http://www.unscear.org/docs/ARES-68-73_e.pdf 18. Doss M. No increased risk of cancer from CT. Letters. AJR 2014;202:W410 19. Ropeik D. Taming radiation fears. The New York Times, October 22, 2013 20. Albert JM. Radiation risk from CT: implications for cancer screening. AJR 2013;201:W81-W87 21. Picano E et al. The appropriate and justified use of medical radiation in cardiovascular imaging: a position document of the ESC Associations of Cardiovascular Imaging, PCI and Electrophysiology. Eur Heart J 2014;35: 66522. Berlin L. Shared decision-making: is it time to obtain informed consent before radiologic examinations utilizing ionizing radiation? Legal and ethical implications. JACR 2014;11:246 23. Truog RD. Patients and doctors -- the evolution of a relationship. N Engl J Med 2012;366;7:581585 24. Pandharipande PV et al. How radiation exposure histories influence physician imaging decisions: a multicenter radiologist survey study. AJR 2013;200:1275 25. Brink JA, Amis ES Jr. Image wisely: a campaign to increase awareness about adult radiation protection. Radiology 2010;247:601 26. Hendee WR, O’Connor MK. Radiation risks of medical imaging: separating fact from fantasy. Radiology 2012;264:312

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Breast MRI

Making Breast MRI available to more patients Packed to overflowing, the audience attending the Bracco lunch symposium on breast MRI at the recent ECR meeting was treated to compelling descriptions of the current status and future prospects of the modality that is considered as the gold standard in the field. Comprising presentations from four luminaries in the field, the symposium communicated the power, potential (and occasional drawbacks) of breast MRI. This article summarises the presentations. Shaping the future of breast MRI

Prof. Thomas Helbich Chairing the session, Prof. Thomas Helbich set the scene by describing how the principles of “P4 Medicine” could be applied to breast imaging. The four “P”s are Predictive, Personalized, Preventive, Participatory • Predictive. This is clearly the area of screening, whose aim is to provide Chairing the Bracco-sponsored sym- early and accurate diagnosis, posium on Breast MRI, Prof Thomas to lead to early intervention Helbich is from the department of and to reduce chronic disBiomedical Imaging and Image-guided Therapy, Medical University of Vienna. ease. Currently mammography is the only screening tool recommended by the WHO. However the disadvantages of mammography are well known — simply put, 15 to 30% of breast cancers are missed by the technique. There is thus no doubt about the need to improve such a situation, which is partially the reason that there is currently a lot of interest in breast tomosynthesis and in increased use of ultrasound. However the drawback of this is that implementation of these approaches in addition to mammography would inevitably result in a significant increase in the number of additional examinations needing to be carried out. In the light of this, Prof. Helbich made a plea for the benefits of the use of MRI in screening, for example in a short protocol lasting less than five minutes. There is already a substantial body of evidence of MRI in screening: approximately 5000 high risk patients have been examined with MRI in eight trials. The sensitivity of MRI was much higher than mammography or ultrasound and its specificity only marginally lower. 18

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Trials have shown that MRI alone is as good as MRI plus mammography or MRI plus ultrasound. The only advantage of retaining mammography would be its ability to identify tiny calcifications, which cannot be picked up on MRI. However these tiny calcifications are low-grade DCIS, which in addition are thought to be principally responsible for “over-diagnosis”. • Personalized, or supplying the right care to the right patient at the right time, so that outcomes can be improved and costs minimized. This aspect inevitably involves the use of biomarkers, i.e. indicators of biological processes, pathological changes, or responses to a pharmaceutical intervention. Everyone is familiar with the use of standard biomarkers such as those derived from blood or urine analysis, histology, etc. However breast MRI can also provide anatomical, functional & molecular parameters. One example is MRI-generated permeability parameters from a DWI procedure. The higher the permeability the more likely that overall survival rate will be be low and vice versa. MRI therefore provides a tool to identify cases that do, or do not, warrant aggressive treatment.

“... The sensitivity of MRI was much higher than mammography and ultrasound and its specificity only marginally lower...” • Preventive. The objective here is to achieve fewer medical interventions, to reduce the use of ionizing radiation and to lower costs. As far as costs are concerned, it shouldn’t be forgotten that the most costefficient method for preventing breast cancer is through life-style changes, e.g. via adopting a healthy diet, with no alcohol, and taking even minimal exercise. The positive effect of healthy living is in fact due to its effect on breast density, whose role has become so well known

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that more and more women are now requesting to know their breast density. This is measured by mammography, a 2D technique, that is not as accurate as 3D MRI. • Participatory. This is the well-recognized need for more interaction between doctors and their patients. At this period when many general radiologists bemoan their distance from, and lack of contact with their patients, the breast imaging community involves radiologists who have the most frequent and most rewarding interaction with their patients. Breast MRI and other diagnostic tools

Prof. Fiona Gilbert

Professor Fiona J. Gilbert holds the chair of radiology, and is head of department at the University of Cambridge School of Clinical Medicine, Cambridge, UK.

With the overall scene set by Prof. Helbich, Prof. Gilbert went about describing in more detail the role of breast MRI, from its principal indications through its pre-eminence as the gold standard for breast examinations to its comparison with other breast imaging techniques.

• Indications for breast MRI.

Detailed descriptions of the many indications of breast MRI are to be found in the guidelines of learned bodies such as the European Society of Breast Cancer Specialists (EUSOMA, www.eusoma.org). Foremost among these indications is the role of MRI as the ultimate method for the solution of indeterminate lesions. If, after all the appropriate work-up has been carried out and yet there is still a doubt regarding a lesion, the recommendation is to carry out an MRI examination. Another generally accepted EUSOMA recommendation is the use of MRI for the screening of high risk women. There is no doubt that, if screening is to be carried out at all in these women, MRI is the method of choice. There is admittedly a lack of firm evidence of the impact of such screening on mortality but at least breast MRI could provide such women with an option to avoid prophylactic mastectomy. Other EUSOMA recommendations for MRI include monitoring neo-adjuvant chemotherapy; breast augmentation or reconstruction, and evaluation of breast cancer recurrence. However a currently highly controversial EUSOMA recommendation is that for the use of MRI examinations in pre-operative staging. The debate was triggered by the findings in 2010 of the original UK-based COMICE trial (Comparative effectiveness of MRI in Breast Cancer) that there was no benefit between women receiving pre-operative MRI and those who did not. Subsequent studies using individual patient data analysis have confirmed this finding. For example in one study after an 8 year follow-up, it was found that local recurrence-free survival was the same in women

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The sensitivity of MRI in the detection of breast cancer is well established as being much higher than that of mammography. However, even if MRI is the “gold standard” against which other techniques are measured, it is important that the MRI exam itself is carried out under optimal conditions. The data above show that different results can be obtained with the use of different MRI contrast agents. MRI results obtained with one of the contrast agents (Multihance) showed the expected significant increase in sensitivity compared to mammography. whereas the use of another contrast agent (Magnevist) showed no significant difference in the level of cancers detected compared to mammography. Image Prof. F Gilbert

having pre-operative MRI as those in women who didn’t. Distant recurrence-free survival was even slightly worse in women who had pre-operative MRI staging compared to those who hadn’t. What makes this issue all the more pointed is the possibility that pre-operative MRI staging could be used to influence the surgical approach, and could in fact lead to inappropriate surgery, for example the substitution of a wide local excision by total mastectomy. This could occur if the MRI staging shows more than the expected number of lesions, triggering a surgical decision to widen the excision, without however the additional lesions ever being confirmed as cancers. • Breast MRI as a gold standard.

A gold standard is one against which other techniques should be compared. For breast MRI, this role is based on the fact that MRI has the highest sensitivity. However this is only true if the MRI is carried out under the best conditions possible, since studies have shown that the sensitivity of MRI can vary according to the specific technique and protocol used and contrast agent chosen. A very recently published study in symptomatic patients highlighted the fact that cancer detection rates were significantly higher with one contrast agent (Multihance) than with another (Magnevist), due to differences in the physiochemical properties of the contrast agents. MRI vs other breast imaging modalities

• MRI vs mammography. With the above reservation regarding the contrast media used, it has been found in screening high

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Breast MRI risk patients that MRI outperforms mammography while MRI together with mammography outperforms MRI alone. The sensitivity of MR is much better than that of mammography but the specificity of mammography is better. • MRI vs Ultrasound. MR outperforms ultrasound for detection and in pre-operative staging has greater sensitivity. In screening high risk patients, the sensitivity of ultrasound is much lower than that of MRI. In symptomatic cases ultrasound performs slightly better; it detects 72% cancers versus 91% for MRI. Again there is a huge difference in the MRI data dependeing on the contrast agent used. • MRI vs digital breast tomosynthesis (DBT). Breast tomosynthesis is currently a highly active field and very promising results have been generated by tomosynthesis, both when compared with conventional mammography or used in addition to mammography. Although there are not (yet) many comparative studies of DBT vs MRI, tomo is undoubtedly here to stay and should be embraced. • MRI vs Contrast-enhanced spectral mammography. CESM is also a highly promising technique and has the potential to challenge MRI. In a recent multi-reader study of 105 cancer and 10 benign lesions, it was shown that both MRI and CESM outperformed mammography; CESM had a better specificity than MRI. • MR vs contrast enhanced digital breast tomosynthesis (CEDBT). The studies carried out so far involve only small numbers of patients but show that the performance of CEDBT has the potential of rivalling that of MRI. • MR vs Photon emitting mammography. PEM looks very promising but a direct comparison with MRI also needs bigger trials. So far it looks as though there is equivalence of (high) sensitivity between MRI and PEM for index lesions, with MRI being better for additional lesions. PEM should not be confused with whole body PET which is not suitable for specific breast examinations. Identifying patients who can benefit from breast MRI

Prof. Francesco Sardanelli Continuing the theme, Prof Sardanelli dealt with how to best identify patients who could benefit from breast MRI. As a general background, he presented an analysis of the published breast cancer literature over the past few decades which showed that, notwithstanding the current interest in breast tomosynthesis, the number of papers dealing with breast MRI Prof. Francesco Sardanelli is at the had continually increased and now Università degli Studi di Milano, IRCCS Policlinico San Donato, Milano, Italy and represented 25% of all papers in the is a member of the European Network area. Despite the recent rapid pace for Assessment of Imaging in Medicine. of technological development in breast MRI, this has however been accompanied by a relatively slow rate of clinical application. One issue that needs to be dealt with right away is the idea that the very high sensitivity of breast MRI and the trade-off with specificity. This does not mean that specificity is low per se. In fact screening studies of high risk patients have shown that specificity can reach 97%, while studies using high-relaxivity

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contrast media have shown that specificity can reach 95-98%. Getting back to the issue of identifying patients who could be candidates for breast MRI, many learned bodies such as the European society of Breast Imaging (EUSOBI), the ACR and EUSOMA have issued guidelines on the indications of breast MRI. Out of these extensive guidelines, some simple rules can be highlighted, e.g. MRI should not be used as an alternative to ultrasound-guided core biopsy or stereo vacuum assisted biopsy. Likewise, the original American Cancer Society algorithm of the use of MRI as an adjunct to mammography can be reversed in the light of the results of the EVA trial and the later HIBCRit study. These showed that there was no added value of mammography (and ultrasound) in the screening of women at increased risk. Thus, in this situation MRI can be used alone, with the subsequent advantage of the elimination of the exposure to ionizing radiation associated with mammography. This is of particular importance in young women with an inherited predisposition to breast cancer e.g. BRCA mutation carriers. However it should be noted that there is one exception to this rule of “breast MRI alone” namely in women with a previous history of chest radiotherapy. In these cases there are a number of DCIS which can only be visualized using mammography. However mammography in this situation is more of an adjunct to breast MRI rather than vice versa.

“... never change a surgical plan from conserving surgery to mastectomy on the basis of an MRI finding that is not confirmed as malignant by needle sampling” One key factor in identifying women who could be candidates for breast MRI is the need to quantify the actual risk of breast cancer. Software is available for the calculation of risk using several models such as the Tyrer-Duffy-Cuzick model. So far there is no evidence not to propose or to stop annual MRI screening for high-risk patients. However there is still a doubt about the benefit of MRI surveillance in reducing breast cancer mortality in patients with. BRCA-1 associated breast cancer. As previously mentioned, the debate on the value of pre-operative MRI is still raging. However in this context there is a simple rule that cuts through all the discussion. This is “never change a surgical plan from conserving surgery to mastectomy on the basis of an MRI finding that is not confirmed as malignant by needle sampling”. There are many aspects in the debate on the value of pre-operative MRI, but one message seems to emerge, namely the women who benefit most from preoperative breast MRI are those who are operated on by a surgeon well trained in using breast MRI for therapy planning, i.e. when the relationship and interaction between radiologist and surgeon is robust and active. Their is also a role for MRI in radiation therapy, particularly in partial breast irradiation (PBI) which is an important approach to reducing over-treatment. However when it was originally introduced, PBI was carried out without MRI. Recent analyses show that the use of MRI would have identified a significant number (maybe 12%) of patients who would have been ineligible for partial breast irradiation. Similarly MRI has a role in the patients undergoing Neo Adjuvant Chemotherapy (NAC), not just to monitor outcome but also during treatment. The key point is once again that the patients who could benefit most from monitoring NAC are those where there is a close collaboration between the radiologist and the relevant professionals. Thus, during NAC treatment when the oncologist changes the NAC regimen

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on the basis of MRI-determined non response and after NAC when the surgeon performs breast-conserving surgery on the basis of MRI-based disappearance of tumor enhancement or tumor shrinkage. Other applications of MRI include occult primary breast cancer, breast implant integrity, as well as new indications such as the high-risk so-called B3 lesions. Here the role of MRI in decisionmaking can be decisive: if MRI shows contrast enhancement, surgery should be undertaken but no enhancement should mean no surgery but rather a wait and see approach. The failure to use MRI in B3 lesions has been estimated to result in huge over-treatment: more than 10 000 unnecessary surgery cases per year in the US and more than 15 000 cases per year in Europe. To sum up, the numbers and categories of women who may benefit from breast MRI are increasing. MRI has a great potential for moving from diagnosis to prognosis. In addition, when preoperative MRI is requested by oncologists for in vivo evaluation of the cancer to be treated, we’ll know that the debate on the use of preoperative MRI will be well and truly over. Abbreviated MRI: optimizing MRI protocols for breast cancer screening

Prof. Christiane Kuhl A fervent believer in the value of breast MRI and a proponent of expanding the application of the modality to screen more women, Prof. Kuhl addressed upfront one of the current criticisms levelled against this approach. This is that, given the significantly increased sensitivity of breast MRI compared to techniques such as mammography or ultrasound, wouldn’t the more Prof. Christiane Kuhl is widespread application of breast MRI just head of the Department of exacerbate the problem of overdiagnosis? Diagnostic and Interventional In the context of mammography screenRadiology, Aachen University ing, overdiagnosis is the accusation that the Clinic, Aachen, Germany. technique picks up cancers which may, in part, be prognostically irrelevant. Wouldn’t the increased sensitivity of breast MRI not just add to this overdiagnosis problem? Dr Kuhl rejects this argument on the simple basis that too many women continue to die of breast cancer. Only if there were no women dying of breast cancer at all could the technology which enables the detection of cancerous lesions be described as overdiagnosis. In fact, despite decades of mammographic screening, breast cancer continues to be the first (in Europe) or second (in the US) most important cause of cancer death in women and is the most common cause of death (from all causes) in women under 50. In addition, breast cancer continues to be the main cause of “life years lost ” in women. On the contrary, Dr Kuhl maintains that the real problem is underdiagnosis caused by breast cancer screening programs failing to detect prognostically relevant disease. Several factors drive the current use of MRI for screening, namely that breast MRI is the most accurate imaging method and the fact that the sensitivity gradient between MRI and mammography or ultrasound is independent of a woman’s personal or familial risk. However in a screening cohort, only a small fraction of women will have breast cancer. Thus, only this relatively small number of women will actually benefit from screening MRI. To improve the benefit/cost ratio, the screening cohort is enriched by offering MRI only to women who

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One of several reasons that breast MRI is not used more often for screening is that the currently available protocol is the full breast MRI diagnostic protocol which takes more than 21 min. To solve this, Prof. Kuhl proposes the use of an abridged protocol taking much less time. Proof of principle trials of the approach have been successfully carried out and show the diagnostic accuracy of the abridged MIP/FAST protocol to be equivalent to that of a full diagnostic protocol, with not even a loss of specificity. Image adapted from Prof. C. Kuhl originals.

carry a high lifetime risk of breast cancer. This indicates that the current allocation of breast MRI is driven not so much by medical considerations but rather by economic considerations, even if these are legitimate in the current general austerity of healthcare finances. In fact, the main reasons why MRI is not used on a broader scale for screening include the high direct and indirect cost and limited availability of the modality. In addition, current breast MRI protocols used for screening are actually identical to the full MRI protocols used for diagnostic purposes. The solution to this is to make breast MRI a real screening tool, by reducing the MR acquisition time, reducing the radiologist’s reading time and have expert breast MR radiologists read the images.

“...the real problem is underdiagnosis caused by breast cancer screening programs failing to detect prognostically relevant disease...” To meet this challenge, Dr Kuhl proposes the use of an abridged protocol with a total time of 3 min. around a central i.v. injection of contrast media as opposed to a typical 20 min. for a full protocol. The principle behind the abridged protocol is to use maximum intensity projection (MIP) images for quick detection of enhancement followed, if necessary, by the use of FAST (First post contrast Subtracted) images for the further categorization of any enhancement. A prospective observational study of the abridged protocol has been carried out. In this, experienced breast MR radiologists rated MIP images as positive or negative depending on the presence or not of enhancement. If necessary FAST images are read to provide BIRADS scores. For scientific completeness a full Diagnostic MRI protocol was also carried out and a final BIRADS score provided. The time to read MIP images is approximately 2.8 seconds and the time to read, if necessary, individual subtracted images approximately 28 seconds. The results of this proof of principle trial showed breast cancers were identified, in fact with a relatively high cancer yield of 18.3 /1000. The diagnostic accuracy of the abridged MIP/FAST protocol is equivalent to that of a full diagnostic protocol, with not even a loss of specificity. In addition the MIP/FAST screening compares favorably to mammographic screening with regard to the time needed to acquire or to review images. Further evaluation of the potential of the abridged protocol is planned.

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Pediatric Radiology By Dr Heike E. Daldrup-Link

Whole Body Diffusion-weighted MR Imaging of Children with Cancer: a solution to the challenge of Long-Term Side Effects from CT Scans It has been shown that the use of 18F FDG PET/CT is superior to conventional imaging modalities such as contrast-enhanced CT and MRI for the staging of most malignant lymphomas. Especially with pediatric patients, however, there is growing concern about the increased risk of secondary tumors developing later in life as a result of the radiation associated with PET/CT. Whole body, diffusion-weighted MRI can image tumors but conventional WB-DW MRI has several disadvantages in pediatric patients, as well as the problem that the enhancement gained with standard MR contrast agents does not last for the duration of a whole body scan. This article summarises our experience using iron supplement ferumoxytol as a contrast agent for improved tumor detection on DW MR scans and describes the potential of the approach in providing necessary pediatric staging with no CT-associated radiation risks.

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maging tests are essential for cancer staging in pediatric patients. However, to date, children with a newly diagnosed solid tumor have to undergo a series of diagnostic imaging procedures, which are stressful, time consuming, in part redundant, expensive and may require repetitive anesthesias. The overaching goal of our research efforts is to develop one single â&#x20AC;&#x153;one stop shopâ&#x20AC;? imaging test, which could provide a comprehensive evaluation of the primary tumor and metastases in one session. Towards this goal, the use of CT and PET/CT staging exams in pediatric oncology patients has grown rapidly during the last several years [1-4]. 18F-FDG PET/CT has been established for staging of most types of malignant lymphoma [5-7]. Many authors have shown, that 18 F-FDG PET or PET/CT is superior to conventional imaging modalities for lymphoma staging, including contrast-enhanced CT, MRI, bone scintigraphy, ultrasonography and Ga-67 scintigraphy [6-12]. The tumor The author Prof Heike E. Daldrup-Link, M.D., Ph.D. is Associate Professor, Department of Radiology Pediatric Radiology Section, Lucile Packard Childrenâ&#x20AC;&#x2122;s Hospital Stanford School of Medicine, 725 Welch Rd, Rm 1665 Stanford, CA 94305-5614, USA Email: H.E.Daldrup-Link@stanford.edu Website: http://daldrup-link-lab.stanford.edu

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extent, diagnosed on 18F-FDG PET/CT, significantly influences treatment decisions and radiation field definition in high risk patients [13]. However, in pediatric patients, using CT images for anatomical co-registration of 18F-FDG PET data has some caveats. CT imaging has been associated with a risk of secondary cancer development later in life [14-16]. This is particularly concerning for young patients, since they are more susceptible to radiation effects than older patients and they live long enough to develop secondary cancers [15-17,18] Pearce et al. reported that cumulative doses from diagnostic CT scans, applied for tumor staging in children, almost tripled the risk of secondary leukemia and brain cancer later in life [19]; and Mathews et al. found a 24% increase in cancer incidence in 11 million Australians who underwent CT scans for cancer staging during childhood and adolescence [20]. Thus, there is an urgent need for new staging tests with reduced or eliminated radiation exposure. In order to solve the conundrum of obligatory diagnostic cancer staging tests and concurrent risk of secondary cancer development later in life, we recently developed an alternative radiation-free staging test, based on whole body diffusion weighted magnetic resonance imaging (WB-DW MR)[21]. Previous approaches for WB-MRI and DW-MRI also imaged tumors [22-24]. But these technologies were not tailored to specific problems of pediatric patients. In children, the spleen and bone marrow show a similar signal compared with tumors on DW MR scans

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Pediatric Radiology

Comparison of ionising radiation-free WB-DW MRI scans (left panel) and 18F -FDG PET/CT scans ( right panel) for the detection of pediatric tumors.

[25]. This can confound tumor detection in those organs. Missed tumors may not be treated and eventually give rise to tumor relapse. In addition, MR scans for anatomical orientation require contrast agent enhancement. However, the enhancement gained with standard MR contrast agents does not persist for the duration of a whole body scan. And finally, DW-MR sequences provide limited background information, similar to FDG PET scans without the CT component, making it difficult to localize a tumor exactly. Ferumoxytol as a contrast agent

We solved these problems by combining anatomical and functional images: we used the iron supplement ferumoxytol (Feraheme) as a contrast agent for improved tumor detection on DW MR scans. Ferumoxytol (Feraheme™ Injection, AMAG Pharmaceuticals) is composed of colloid-based iron oxide nanoparticles, which consist of an iron oxide core with a size of 6.4 –7.2 nm and a carboxydextran coat with a hydrodynamic diameter of 28–32 nm [26-30]. In June 2009, the FDA approved ferumoxytol for intravenous treatment of iron-deficiency anemia in adult patients with chronic kidney disease. Our group and others have shown that ferumoxytol is an effective contrast agent for MR imaging [26-30]. At 20 MHz and 39°C, ferumoxytol demonstrates an r1 relaxivity of 38 mM–1s–1, an r2 relaxivity of 83 mM–1s–1 and a blood-half live of 67 minutes in rodents 26-30. The resultant “blood pool enhancement” on T1-weighted MR images can be used to achieve long last-

The cartoon above is used as a reminder of the undesirability of exposing pediatric patients to ionizing radiation. However until now, the best way of carrying out the important proces of staging pediatric tumors has been though use of PET/CT. Radiation-free WB-DW MRI using iron oxide nanoparticles as contrast agent may be the way to solve the conundrum .

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ing vessel delineation on T1-weighted MR images and the uptake of the nanoparticles by macrophages in the reticuloendothelial system (RES) can help to delineate tumor deposits in liver, spleen and bone marrow on T2- and DW images. By fusing radiation free images that highlight the tumor with contrast-enhanced MR scans that provide a very detailed anatomical map of the body, we created radiation-free images that shows us more clearly, where tumors are in relation to anatomical landmarks. Clinical perfomance of radiation-free WB-DW MRI

Our radiation free WB-DW MR imaging technique detected 158 of 174 malignant tumors and FDG-PET/CT detected 163 of 174 malignant tumors [21]. The resultant sensitivities, specificities, and diagnostic accuracies were all excellent, with values above 90%, and were not significantly different between the two imaging modalities [21]. Tumour staging results also showed very good agreement between both imaging modalities with a κ of 0.93. At the same time, the associated radiation exposure could be reduced from about 12.5 mSv for the PET scans to zero for the WB-DW scans. Both exams required roughly the same time between tracer injection and end of scan and the estimated exam costs were comparable. Safety Profile of iron oxide nanoparticle MRI contrast agents

Of note, our team has applied various iron oxide nanoparticle compounds as MR contrast agents in phase I-IV clinical trials [31-38]. These agents are generally well tolerated and show excellent safety profiles [35-37,39,40]. Considering a Ferumoxytol dose of 5 mg/kg and a concentration of 30 mg Fe/ml, a teenager with an average body weight of 50-80 kg would receive a dose of 250-400 mg Fe (note, these are coated iron particles, not free iron). This iron dose is lower than the FDA-approved ferumoxytol dose for anemia treatment and comparable to the iron dose administered with one blood transfusion. Ferumoxytol has been safely applied in more than 150,000 adult patients to date. Anaphylaxis or anaphylactoid reactions to ferumoxytol were reported in 0.1-0.2% of exposed adult patients, which is comparable to other MR contrast agents [40-42] . We and others did not observe any adverse effects in our pediatric patients so far 43. Ferumoxytol is not excreted via the kidneys and thus, not associated with any risk of nephrogenic sclerosis (a potential adverse event with Gdchelates) [40-42]. In our study, we investigated the use of ferumoxytolenhanced WB-DW MRI for initial staging only and additional studies need to show the utility of this technique for treatment monitoring. A reduced radiotracer uptake on a PET/CT scan after two cycles of chemotherapy compared to the initial scan has shown to predict overall response and outcome in patients with malignant lymphomas and is currently used to stratify patients to more or less aggressive therapies. We have to prove that we can generate that same information with our technique and this is a major focus of a recently initiated multi-center initiative.

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Conclusion and Future Prospects

In the era of personalized medicine, we are trying to create the most accurate, most efficient, savest and most costeffective imaging test for each individual patient. We assume that the radiation-free WB-DW MRI test will be particularly attractive for young children, for patients with benign diseases, for patients with an increased susceptibility to radiation effects and for patients with a genetic predisposition for cancer development, who have to undergo many imaging procedures throughout their lives for cancer screening. For other patients, we may still need the information from metabolic PET scans and this refers specifically to treatment monitoring. We are in the process of performing additional studies that evaluate the value of WB-DW scans with and without addition of PET data for treatment monitoring. The combination of PET and MR data would still eliminate radiation exposure from CT scans and substantially reduce radiation exposure by up to 80%. Future studies will have to show, which patients will benefit most from a completely radiation-free WB-DW MR imaging test, as described in our article, versus new integrated PET/MR imaging tests. This is a major focus of our future multiinstitutional research efforts. Acknowledgement

The Lancet Oncology kindly granted permission to reproduce images and text originally presented in the more complete paper, Reference 21 below. References 1.Federman N, Feig SA. PET/CT in evaluating pediatric malignancies: a clinician’s perspective. Journal of nuclear medicine : official publication, Society of Nuclear Medicine 2007;48:1920-2. 2.Tatsumi M, Miller JH, Wahl RL. 18F-FDG PET/CT in evaluating non-CNS pediatric malignancies. Journal of nuclear medicine : official publication, Society of Nuclear Medicine 2007;48:1923-31. 3. Gerth HU, Juergens KU, Dirksen U, Gerss J, Schober O, Franzius C. Significant benefit of multimodal imaging: PET/CT compared with PET alone in staging and follow-up of patients with Ewing tumors. Journal of nuclear medicine : official publication, Society of Nuclear Medicine 2007;48:1932-9. 4. Kleis M, Daldrup-Link H, Matthay K, et al. Diagnostic value of PET/CT for the staging and restaging of pediatric tumors. Eur J Nucl Med Mol Imaging 2009;36:23-36. 5.  Bakhshi S, Radhakrishnan V, Sharma P, et al. Pediatric nonlymphoblastic non-Hodgkin lymphoma: baseline, interim, and posttreatment PET/ CT versus contrast-enhanced CT for evaluation--a prospective study. Radiology 2012;262:956-68.

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6. London K, Cross S, Onikul E, Dalla-Pozza L, Howman-Giles R. 18F-FDG PET/CT in paediatric lymphoma: comparison with conventional imaging. Eur J Nucl Med Mol Imaging 2011;38:274-84. 7. Riad R, Omar W, Kotb M, et al. Role of PET/CT in malignant pediatric lymphoma. Eur J Nucl Med Mol Imaging 2010;37:319-29. 8.  Kabickova E, Sumerauer D, Cumlivska E, et al. Comparison of 18F-FDG-PET and standard procedures for the pretreatment staging of children and adolescents with Hodgkin’s disease. European journal of nuclear medicine and molecular imaging 2006;33:1025-31. 9. Amthauer H, Furth C, Denecke T, et al. FDG-PET in 10 children with non-Hodgkin’s lymphoma: initial experience in staging and follow-up. Klinische Padiatrie 2005;217:327-33. 10. Miller E, Metser U, Avrahami G, et al. Role of 18FFDG PET/CT in staging and follow-up of lymphoma in pediatric and young adult patients. Journal of computer assisted tomography 2006;30:689-94. 11. Furth C, Denecke T, Steffen I, et al. Correlative imaging strategies implementing CT, MRI, and PET for staging of childhood Hodgkin disease. Journal of pediatric hematology/oncology 2006;28:50112. 12. Murano T, Tateishi U, Iinuma T, et al. Evaluation of the risk of radiation exposure from new 18FDG PET/CT plans versus conventional X-ray plans in patients with pediatric cancers. Annals of nuclear medicine 2010;24:261-7. 13. Robertson VL, Anderson CS, Keller FG, et al. Role of FDG-PET in the definition of involved-field radiation therapy and management for pediatric Hodgkin’s lymphoma. International journal of radiation oncology, biology, physics 2011;80:324-32. 14.  Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med 2007;357:2277-84. 15. Hall EJ, Brenner DJ. Cancer risks from diagnostic radiology. The British journal of radiology 2008;81:362-78. 16. Robbins E. Radiation risks from imaging studies in children with cancer. Pediatr Blood Cancer 2008;51:453-7. 17. Brenner DJ, Doll R, Goodhead DT, et al. Cancer risks attributable to low doses of ionizing radiation: assessing what we really know. Proc Natl Acad Sci U S A 2003;100:13761-6. 18. Health Risks from Exposure to Low Level of Ionizing Radiation: BEIR VII Phase 2. Board on Radiation Effects Research (BRER). The National Academic Press2006. 19. Pearce MS, Salotti JA, Little MP, et al. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet 2012;380:499505. 20. Mathews JD, Forsythe AV, Brady Z, et al. Cancer risk in 680 000 people exposed to computed tomography scans in childhood or adolescence: data linkage study of 11 million Australians. Bmj 2013;346:f2360. 21.  Klenk C, Gawande R, Uslu L, et al. Ionising radiation-free whole-body MRI versus F-fluorodeoxyglucose PET/CT scans for children and young adults with cancer: a prospective, non-randomised, single-centre study. The Lancet oncology 2014. 22. Byun WM, Shin SO, Chang Y, Lee SJ, Finsterbusch J, Frahm J. Diffusion-weighted MR imaging of metastatic disease of the spine: assessment of response to therapy. AJNR American journal of neuroradiology 2002;23:906-12. 23. Darge K, Jaramillo D, Siegel MJ. Whole-body MRI in children: current status and future applications. European journal of radiology 2008;68:289-98. 24. Kwee TC, van Ufford HM, Beek FJ, et al. Wholebody MRI, including diffusion-weighted imaging, for the initial staging of malignant lymphoma: comparison to computed tomography. Investigative radiology 2009;44:683-90.

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25. Rosset A, Spadola L, Ratib O. OsiriX: an opensource software for navigating in multidimensional DICOM images. Journal of digital imaging : the official journal of the Society for Computer Applications in Radiology 2004;17:205-16. 26. Lin EY, Li JF, Gnatovskiy L, et al. Macrophages regulate the angiogenic switch in a mouse model of breast cancer. Cancer Res 2006;66:11238-46. 27.  Crowther M, Brown NJ, Bishop ET, Lewis CE. Microenvironmental influence on macrophage regulation of angiogenesis in wounds and malignant tumors. Journal of leukocyte biology 2001;70:478-90. 28. Leek RD, Lewis CE, Whitehouse R, Greenall M, Clarke J, Harris AL. Association of macrophage infiltration with angiogenesis and prognosis in invasive breast carcinoma. Cancer Res 1996;56:4625-9. 29. Mantovani A, Bottazzi B, Colotta F, Sozzani S, Ruco L. The origin and function of tumor-associated macrophages. Immunol Today 1992;13:265-70. 30.  van Netten JP, Ashmed BJ, Cavers D, et al. ‘Macrophages’ and their putative significance in human breast cancer. Br J Cancer 1992;66:2201. 31.  Daldrup-Link HE, Kaiser A, Link TM, et al. Comparison between gadopentetate and feruglose (Clariscan)-enhanced MR-mammography: preliminary clinical experience. Acad Radiol 2002;9 Suppl 2:S343-7. 32. Daldrup-Link HE, Rummeny EJ, Ihssen B, Kienast J, Link TM. Iron-oxide-enhanced MR imaging of bone marrow in patients with non-Hodgkin’s lymphoma: differentiation between tumor infiltration and hypercellular bone marrow. Eur Radiol 2002;12:1557-66. 33.  Daldrup-Link HE, Brasch RC. Macromolecular contrast agents for MR mammography: current status. Eur Radiol 2003;13:354-65. 34.  Daldrup-Link HE, Kaiser A, Helbich T, et al. Macromolecular contrast medium (feruglose) versus small molecular contrast medium (gadopentetate) enhanced magnetic resonance imaging: differentiation of benign and malignant breast lesions. Acad Radiol 2003;10:1237-46. 35.  Daldrup-Link HE, Rydland J, Helbich TH, et al. Quantification of breast tumor microvascular permeability with feruglose-enhanced MR imaging: initial phase II multicenter trial. Radiology 2003;229:885-92. 36.  Simon G, Link TM, Wortler K, et al. Detection of hepatocellular carcinoma: comparison of Gd-DTPA- and ferumoxides-enhanced MR imaging. Eur Radiol 2005;15:895-903. 37. Metz S, Lohr S, Settles M, et al. Ferumoxtran10-enhanced MR imaging of the bone marrow before and after conditioning therapy in patients with non-Hodgkin lymphomas. Eur Radiol 2006;16:598-607. 38. Daldrup-Link HE, Mohanty A, Cuenod C, Pichler B, Link T. New perspectives on bone marrow contrast agents and molecular imaging. Semin Musculoskelet Radiol 2009;13:145-56. 39.  Spinowitz BS, Kausz AT, Baptista J, et al. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol 2008;19:1599-605. 40. Lu M, Cohen MH, Rieves D, Pazdur R. FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease. Am J Hematol 2010;85:315-9. 41. Coyne DW. Ferumoxytol for treatment of iron deficiency anemia in patients with chronic kidney disease. Expert Opin Pharmacother 2009;10:25638. 42. Schwenk MH. Ferumoxytol: a new intravenous iron preparation for the treatment of iron deficiency anemia in patients with chronic kidney disease. Pharmacotherapy 2010;30:70-9. 43. Hassan N, Cahill J, Rajasekaran S, Kovey K. Ferumoxytol infusion in pediatric patients with gastrointestinal disorders: first case series. The Annals of pharmacotherapy 2011;45:e63.

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Industry News

Esaote’ s new man at the top talks of his first year in charge Carlos Alonso joined the Esaote company as Chief Executive Officer just over a year ago. A leading player in the biomedical equipment sector, Esaote has a particular focus on ultrasound, dedicated magnetic resonance and software for managing the diagnostic process. The company is internationally recognized as one of the “Top Ten” principal diagnostic imaging companies in the world. Diagnostic Imaging Europe caught up with Carlos at the recent ECR meeting and asked him about his first full year in charge.

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. Before we get on to your time at Esaote could you please tell us about your career path prior to when you took over as CEO of Esaote in February 2013. Sure. It’s a long time ago now, but I began my professional career more than 22 years ago, when I was country manager for Dentsply in Spain. After that I spent 15 years working for Baxter, the multinational diversified healthcare company, with products ranging from medical devices, pharmaceuticals through to biotechnology. I ended up as president of Baxter’s renal division, based at corporate headquarters in Chicago, IL, USA and with responsibility for a global business worth more than 3 billion dollars. I then decided to go back to Europe .

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. So why did you join Esaote? Well I wanted to use my experience in the healthcare business in general, but I was particularly attracted to the medical imaging sector within healthcare since there is no doubt that imaging is set to grow at a faster rate than many other areas in healthcare. This is particularly true for ultrasound, where growth is being pushed by several factors such as the increasing diagnostic power of sophisticated technology as well as the more general factor of the increasing needs of the ageing population. Also I looked forward to the challenger of transforming a company with a basic Italian background into a truly multinational company capable of taking on and succeeding in the very competitive market place which is currently dominated by conglomerates. And speaking of the perception that many people have of Esaote being Italian, the facts are that actually

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more than 70% of our company’s annual € 325 million sales are generated in non-Italian, international markets. Likewise, we are based in Genoa, Italy, but have R&D and production plants in Italy, the Netherlands and China. More importantly, we have active scientific and clinical collaborations with clinical research centres and universities throughout the world.

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. So what has your first year in charge been like? Basically my first year in charge was devoted to strengthening the underlying basic conditions of the business to accelerate growth in 2014. This of course is ‘preparatory’ work, involving changes in our structure, in the functionality of the organization and in investments in terms of geographic expansion. The overall objective of the changes are aimed at making the company more agile, more competitive and more customer-oriented.

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. Now with one more than one year in charge under your belt, how do you see the strengths of the company ? Of course it takes some time to get the true feel of a company when you take over as CEO. But now I can see clearly that Esaote has several unique aspects which make us very competitive. These are: 1) Horizontal integration. We have a unique value proposition: providing a full spectrum coverage, from prevention and diagnosis to therapy and follow-up. We can provide global clinical solutions for specific pathologies, offering systems which help users to make good analyses and diagnoses (through US/MRI) but also allowing them to perform therapy, for example by US-guided laser ablation, and follow-up. 2) Another feature, which is sometimes taken for granted but is nevertheless vital, is our intense customer-focus. We really believe that the way to succeed is to be very clinically oriented. We know that we must understand our customers’ needs to provide the most suitable solutions. This is one of our main values and strategic imperatives. Being customer-oriented means not just offering our customers products with the right level of engineering and technology but, above all, in enabling clinicians to actually do their job better, such as being competitive e.g. in the face of a larger competitive hospital or of a another clinician. Or putting it another way, our mindset is about what the customer can actually DO with our products and what benefits they bring.

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• But we are also counting on growth in UK, France and Germany, where we made big changes in 2013. After all that it will then be time to focus on growth in emerging economies:

In practice, one way that we used to reach this aim was the creation of a Scientific Affairs function in our organization, in order to give a more clinical orientation to the company. 3) Of course all this may sound like fine words, but backing it all up, we also have a really strong product portfolio. We have good diagnosis systems with very easy and unique software systems that help users make reliable analytical and diagnostic decisions in multipurpose environments, which boils down to us needing us to produce high quality images. In addition to our full portfolio of ultrasound and dedicated MRI systems we also have PACs and quantitative analytical software but are also strengthening our position in the interventional business, where we give our customers the ability to make therapeutic interventions through ultrasound-guided laser ablation systems.

• China: we’ve grown consistently year on year in China, and will continue to do so in 2014. In China, we’re extremely proud of our ultrasound systems, and the fact it’s our second biggest market. Twenty years ago, we identified that China would be a key market, and so far our strategy there has been good: we occupy fourth position as far as market share is concerned. The challenge is how to continue to grow and maintain our market position. We plan to increase our penetration in the provincial and regional hospitals and later on in very small, local clinics/practices. • In Brazil, we carried out important adjustments in 2013 and we are ready to grow in 2014. • We’re making important investments in terms of our geographic expansion where previously we operated with distributors – e.g. in Nordics, Australia, New Zealand, Mexico and Colombia (Latam North). In summary, all this boils down to a combination of getting growth back in Europe (Italy), growth in key markets such as the USA - and in new markets (i.e. Brazil, New Zealand etc.)

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With its ability to synchronize in real-time with therapeutic applications such as the Echolaser ablation device, the newly introduced Crystaline system from Esaote is an example of the company’s policy of horizontal integration..

. What about the future? I am optimistic about growth in the rest of 2014. We will accelerate growth in our key markets. These are : • The USA which is one of key targets for growth in next 5 years, where we are investing in quality and in quantity. • However, although I said that we are more and more internationally oriented, the fact is that Italy still provides over 35% of our sales, which of course we must continue to nurture. To do this, we have reorganized the structure of the Italian business, with the aim of reinstating Esaote’s growth at home. APRIL/MAY 2014

. So to sum up? It’s simple: It’s all about the evolution of the company. Our efforts are twofold: 1.To make Esaote a global company, a real corporate organization 2. To manage successfulli the transition from a product/technology focussed to a much more customeroriented company. All that will be made possible by improving our portfolio, sales and marketing effectiveness and organizational efficiency. I look forward to the future with confidence. D I

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Innovative clinical ultrasound hardware and software The technical capabilities of the new CrystaLine system from Esaote provide a valuable interventional tool which breaks away from “diagnosis - only” ultrasound into the therapeutic arena. This latest hardware and software upgrade significantly improves the image quality and depth of field and enable clinicians to undertake interventional procedures with confidence. CrystaLine incorporates specific hardware and software features that build on the advanced eHD ultrasound technology that Esaote introduced last year.

eHD is the Esaote technology that innovates ultrasound imaging by optimizing all the aspects of the chain through which a signal has to travel..

Other major technical improvements provided by CrystaLine include Combined Pulse Imaging Technology which effectively increases depth-offield, improving the imaging of structures deeper in the body. Combined with the new XView+ speckle-noise reduction system, fully adjustable by the operator, helps to produce an optimal personalised image. The reality of higher quality, clearer imaging at increased depth, now enables clinicians to confidently use ultrasound in borderline examinations and interventional ultrasound procedures. Carlos Faustmann, Esaote’s Chief Global Marketing Officer, explains: “Ultrasound is highly valued for its safe, non-invasive nature. One of the challenges has been capturing high quality images in those technically difficult patients. CrystaLine changes all that.” “In addition, CrystaLine enables clinicians to synchronise with interventional systems such as medical lasers,” continues Faustmann. “This feature is an example of the huge potential for Esaote and ultrasound in direct therapeutic applications.” Esaote Genoa, Italy, www.esaote.com

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Glasgow, UK

September 13-17

CIRSE 2014 The CIRSE Annual Meeting is by far the largest and most significant platform for minimally invasive, image-guided medicine, welcoming over 6,500 delegates from 94 countries in 2013. CIRSE 2014 will offer over 250 hours of scientific and educational content transmitted through a range of formats, including special focus sessions, hands-on workshops, interactive case discussions, electronic posters, debates, a state-of-the-art technical exhibition and much more.

• • • • • •

MAIN TOPICS

Vascular Interventions Transcatheter Embolisation Non-Vascular Interventions Interventional Oncology Neurointerventions IR Management

Register Now Early Bird Fe ! es available For more information please visit us at: www.cirse.org

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Check out highlights from past congresses and the latest Society updates here: www.esir.org – the largest educational platform in the field facebook.com/CIRSEsociety youtube.com/CIRSEsociety

Cardiovascular and Interventional Radiological Society of Europe


Women’s Health By Prof Andy Evans

Comparing Histologic Prognostic Features of Invasive Breast Cancer With Mean Stiffness Using ShearWave Elastography

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recently published study [1] was conducted by the author and colleagues comparing the prognostic value of histologic features of invasive breast cancer for the lesion’s mean stiffness as measured by ShearWave™ Elastography (SWE™). The quantitative measurement of a lesion’s stiffness can be achieved, in kilopascal with SWE, during a routine ultrasound breast examination. Two published studies have already demonstrated SWE to be accurate in helping the differentiation of probably benign and probably malignant solid breast masses, with a very high level of reproducibility. The technology therefore holds promise as a diagnostic tool for women who are recalled because of mass lesions at mammographic screening as well as with symptomatic masses. In terms of radiologic appearance and behavior, invasive breast cancer is a heterogeneous disease. Both in pathologic prognostic features and radiologic appearance correlations have been found. It can be clinically useful to recognize such findings, such as with the poor correlations between the histologic size [Figure 1] of invasive lobular carcinoma with its mammographic and US size. The appearance of the basal-phenotype cancers seen often in BRCA1 carriers on mammographic and US images [figure 2] is another example of misleadingly benign appearance. Invasive breast cancers are usually stiffer than normal and benign tissues and often display areas of stiffness that are larger than the morphological area [Figure 3]. The study aim was to compare the prognostic value of histologic features of invasive breast cancers for their stiffness. As such SWE™ was an indispensible tool for

the visualization of breast masses and their stiffness measurement in this study. In fact the study showed that invasive cancers with poor prognostic features had higher mean stiffness values than cancers with good prognostic features. There was a statistically significant positive association of mean stiffness with several histologic features, such as the high histological grade, increased size of the cancers, lymph node involvement, and increased vascular invasion. A

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The Author Prof. Andy Evans Professor of Breast Imaging,

FIGURE 1. Invasive Lobular Carcinoma. A 66-year old patient presented with a symptomatic clinically indeterminate left breast lump. A. The tumour was mammographically occult in a BIRADS 4 density breast. B. A lobulated mixed echogenic mass was demonstrated on B-mode imaging. C. There was a surrounding stromal stiffness on SWE. D. Histology (x20) showed a typical single file linear streaming, «indian-file» appearance of carcinoma cells within the fibrous tissue.

University of Dundee Hon Consultant Radiologist, NHS Tayside Ninewells Hospital & Medical School Dundee, Scotland, UK. email a.z.evans@dundee.ac.uk

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Women’s Health A

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FIGURE 2. Medullary Carcinoma. A 56-year old patient presented with a small palpable breast lump in her left breast showing tenderness. A. A small well defined mass was visualised on mammograms. B. Ultrasound demonstrated a slightly lobulated hypoechoic lesion with minor posterior attenuation. C. The peritumoural stroma was stiffer than the surrounding tissue and than the lesion itself. D. Histology (x10) demonstrated a syncytial growth pattern and abundant mononuclear cell infiltrate.

Patients and Methods

Between April 2010 and March 2011, 101 women of mean age 61 (range of 38-91) with solid breast lesions were imaged with the Aixplorer ultrasound system (SuperSonic Imagine) in gray scale and then in ShearWave™ Elastrography mode. Lesions were all visible on the scans and a core needle biopsy confirmed invasive cancers. Patients subsequently underwent primary surgical treatment. Sixty-four of the women had presented with breast symptoms and 37 women had screening-detected cancer. Of the cancers in the study group, 54% were smaller than 20 mm in invasive size at pathologic examination, 37% were node positive, 28% had vascular invasion, 11% were grade 1, 45% were grade 2, and 44% were grade 3. For each lesion, four elastographic images were obtained in two orthogonal planes. This was done by holding the probe still without the application of pressure and allowing the image to build up over approximately 10 seconds. By moving a delineated region of interest (ROI) over the color map, the mean stiffness measurements were obtained. The figures change in real time so the ROI can be moved to the stiffest part of the image as the ROI moves. The ROI was kept as small as possible to allow measurement of the stiffest tissue anywhere within or adjacent to the lesion as many cancers are not uniformly stiff but have a halo of peritumoural stiffness. 30

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FIGURE 3. Invasive Ductal Carcinoma of no specific type (NST). This mass was screen-detected in a 71-year old patient. A. On mammography, there was a 2cm spiculate mass deep to the nipple. B. On ultrasound, an irregular hypoechoic lesion was visible, with associated penetrating vascularity. C. SWE demonstrated a ring pattern of increased stiffness, with a superficial focus of marked stiffness. D. Histology (x10) showed a fibrofatty breast tissue, infiltrated by pleomorphic tumour cells with a high mitotic index, and no specific features.

The histologic features, on the basis of the surgically resected specimen, were correlated with the mean stiffness measured with SWE™. Histological features were the histologic grade (Elston and Ellis method) tumor type, the invasive size at pathologic examination, the vascular invasion status, and the lymph node invasion status. By using cut-off points at 50 kPa and 150 kPa, the data were divided into three groups. The cut of point used for benign versus malignant differentiation in a previous preliminary study was, fifty kilopascals, while 150 kPa was close to the average stiffness observed in this series for an invasive breast cancer. Statistical Correlation

The mean coefficient of variation of stiffness readings was 25.8+/-14.2. The intraclass correlation coefficient was 0.64. Higher histologic grade was associated with higher mean stiffness (P = 0.0001). The difference in mean stiffness was more marked between invasive cancers grade 1 and 2 than between grade 2 and 3 At univariate analysis, larger invasive size (P<0.0001), axillary lymph node involvement (P<0.0001), tumor type (P<0.0001), and vascular invasion (P = 0.0077) all showed significant associations with higher mean stiffness values. Multiple linear regression indicated that the invasive size was the strongest pathologic determinant of mean stiff- ness (P<0.0001),

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A

Particularly among young women, it is common practice for a benign diagnosis to be made on the basis of clinical and US findings without immediate biopsy. The accuracy of modern gray-scale US in differentiating malignant from benign masses has made this possible. ShearWave Elastography is likely to lead to an expansion in the number of lesions that can be accepted as benign without percutaneous biopsy (figure 4) when added to gray-scale US clinical findings. Since tumors might be confused with benign disease, it is important to explore which sub-groups of breast cancer are associated with low stiffness at ShearWave Elastography. This can help radiologists to understand the technique’s potential pitfalls. A 50-kPa cutoff was derived from the initial 10 patients and prospectively applied to 53 further patients in a previous preliminary study. A sensitivity of 97% and specificity of 83% resulted from use of this cut off. Different cut-off values could be chosen, however, since stiffness is a continuous variable. If improved specificity was desired, for instance, a higher cut-off could be used but the sensitivity would be reduced.

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FIGURE 4. Invasive Papillary Carcinoma. This palpable breast lump was found in the right breast of a 63-year old patient. A. Mammogram demonstrated a well circumscribed breast mass. B. Ultrasound with Doppler flow showed peripheral vascularity around a homogeneously hypoechoic well defined mass. C. Subtle peritumoural stromal stiffness was visible on SWE. D. Histology (high power) demonstrated the presence of monotonous epithelial cells with poorly formed cytoplasmic cores.

with histologic grade also having a significant influence (P = 0.022) Conclusion

High histological grade, large invasive size, lymph node involvement, and vascular invasion all show, on the basis of univariate analysis statistically significant associations with

increased mean stiffness values, as measured by ShearWave™ Elastography. A larger invasive size and a higher histological grade, were found to be significantly associated with increased SWE™ stiffness of invasive breast cancer at multivariate analysis. References 1. E  vans A, Whelehan P, Thomson K, McLean D, Brauer K, Purdie C, Baker L, Jordan L, Rauchhaus P, & Thompson A. Radiology. Invasive breast cancer: relationship between shear-wave elastographic findings and histologic prognostic factors. 2012 Jun; 263(3): 673-7. doi: 10.1148/ radiol.12111317. Epub 2012 Apr 20.

Book review Vascular Imaging of the Central Nervous System:

Physical Principles, Clinical Applications and Emerging Techniques Ed by Joana Ramalho & Mauricio Castillo Pub by Wiley-Blackwell, March 2014, 432 pages. Hardcover € 133; E-book € 109.99 The last ten years has seen vascular imaging of the central nervous system (CNS) evolve from fairly crude, invasive procedures to more advanced imaging methods that are safer, faster, and more precise—with computed tomographic (CT) and magnetic resonance (MR) imaging methods playing a special role in these advances. Vascular Imaging of the Central Nervous System is the first full-length reference text that shows radiologists—especially neuroradi-

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ologists—how to optimize the use of the many techniques available in order to increase the sensitivity and specificity of vascular imaging, thereby improving the diagnosis and treatment of individual patients. Each chapter is formatted carefully and divided into two essential parts: The first part describes the physical principles underlying each imaging technique, along potential associated artifacts and pitfalls; the second part addresses clinical applications and novel applications of each method.

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Powerful Performance to Meet All Your Ultrasound Needs Only the Aixplorer ultrasound system combines: ®

Impeccable image quality to improve diagnosis An UltraFast™ Platform to bring you true technological advancement Real-time, quantitative, ShearWave™ Elastography on all transducers and across a variety of clinical applications

“ The Aixplorer ® is one of the best systems

on the market. It’s easy to use, and thanks to SuperSonic Imagine’s commitment to their customer needs, we were able to discuss our clinical challenges and see the implementation of our suggestions.

Prof. Fritz Schäfer, MD Kiel, Germany

Liver / Prostate / Thyroid / Vascular / Musculoskeletal / Abdomen / Gynecology / Obstetrics / Breast / Breast 3D / Pediatrics The SuperSonic Imagine Aixplorer® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, OB-GYN, Pelvic, Pediatric, Neonatal Cephalic, Urology, Trans-rectal Trans-vaginal and Brain* (*only for Europe)


IND USTRY NEWS Guerbet to collaborate on clinical studies in primary and secondary liver cancer A pioneer in the field of contrast agents and with more than 80 years of experience, the French company Guerbet is the only pharmaceutical group fully dedicated to medical imaging worldwide. As such it has a complete offering of contrast products for X-ray and MRI and for interventional radiology, along with a range of injectors and related medical equipment to provide improved diagnosis and treatment of patients.

One of the company’s earliest products was Lipiodol Ultra Fluid which was initially developed many years ago for diagnostic radiology in indications including liver lesion diagnosis, lymphography and hysterosalpingography. With its well-established safety profile, the product has also been used in interventional radiology for conventional trans-arterial chemo-embolization (cTACE) procedures of multinodular hepatocellular carcinoma. In these applications, Lipiodol Ultra Fluid is used not only as a procedure visualizer (contrast agent) but also as a drug vehicle (drug carrier and eluter) and an embolic. The cTACE procedure has been widely reported in the peer-reviewed scientific and clinical literature including descriptions of over 100 clinical studies, of which 12 were international

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randomized controlled trials. A total number of more than 10,000 patients with intermediate stage HCC have undergone cTACE. The procedure has recently been established as the standard-of-care for the treatment of patients with intermediate stage HCC by three international clinical consensus guidelines in Japan, Europe and the United States. Guerbet have now announced that they have established a collaboration with the Australia-based Sirtex Medical to pursue major clinical studies in primary and metastatic liver cancer. The objective of the collaboration is to examine how Sirtex’s SIR-Spheres microspheres and Guerbet’s Lipiodol Ultra Fluid may be combined optimally — and further developed — to address the significant unmet clinical need in patients with hepatocellular carcinoma, metastatic colorectal cancer, metastatic neuroendocrine tumors and a range of other primary and secondary liver cancers. Sirtex’s SIR-Spheres microspheres are used in selective internal radiation therapy (SIRT), also known as radioembolization, for the treatment of patients with inoperable liver tumors. The microspheres have been shown in randomized controlled trials to increase survival in patients with inoperable liver metastases from primary colorectal cancer. Sirtex’s Chief Executive Officer, Gilman Wong said that “We hope that through this clinical studies collaboration we can make further gains for the benefit of the patients with liver cancer. Should the initial collaboration prove fruitful, future collaborations in R&D and marketing between Sirtex and Guerbet will be considered”. Guerbet’s Chief Executive Officer, Yves L’Epine, said “We are excited about the potential of combining or sequencing our products to improve the efficacy of interventional radiology procedures in patients with unresectable hepatic tumors. Indeed, while Lipiodol and SIR-Spheres individually are well proven and widely used therapies in their own right, they have never been formally evaluated together or sequentially”. Guerbet Villepinte, France www.guerbet.com D I

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Carestream to supply PACS for French TéléSanté Project The Groupement de Coopération Sanitaire (GCS) TéléSanté Centre in France has just announced that it has selected Carestream Health to provide PACS, archiving and medical image sharing and exchange solutions for its public and private health organizations in the Centre region of France, which straddles the middle Loire Valley.

This progressive project, which is supported by the French Ministry of Health, the Regional Health Agency, the Hospital Federation of France and G4, the professional council of radiology, will encompass more than 20 hospitals and imaging centres. It will allow all medical imaging produced in the region to be shared regardless of location and will play a leading role in providing the architecture for establishing a regional imaging patient record. Clinicians will benefit from simplified search and retrieval of previous imaging studies, powerful diagnostic and postprocessing tools and improved enterprise workflow. Throughout the tendering process, Carestream demonstrated the benefits of being a single provider and its ability to supply a highly effective and affordable proposition that took account of existing solutions. This applied particularly to CARESTREAM Vue PACS, which when combined with Carestream’s Vue Connect platform, consolidates reading, reporting, advanced 3D processing, archiving and distribution into a single access point across multiple sites for improved patient care at reduced cost. Carestream has considerable experience in providing Cloud-based services to 33


1 2 8 1 JUNE G R U B Z SAL STRIA AU

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an Europe y t Socie ointestinal r of Gast ominal d b A and gy lo io Rad

Deadline Pre-Registration with reduced fees: May 20, 2014! CT COLONOGRAPHY HANDS-ON WORKSHOPS 21st Hands-on Workshop on CT Colonography October 8 – 10, 2014, Leeds, United Kingdom Workshop organiser Damian Tolan

LIVER IMAGING WORKSHOPS 14th Liver Imaging Workshop September 11 – 12, 2014, Bologna, Italy Workshop organiser Rita Golfieri, Luigi Grazioli

MULTIDISCIPLINARY ESGAR/ESCP WORKSHOP ON BOWEL DISEASES 2nd Multidisciplinary Bowel Imaging Workshop December 12 – 13, 2014, Lisbon, Portugal Local organiser Celso Matos

Information on all ESGAR Activities can be found on www.esgar.org


Industry NEWS a number of projects in France and the maturity and flexibility of its platform will enable rapid deployment to the MIRC project from the second quarter of this year. “We have been operating Vue for Cloud-based services in France now for more than seven years and have considerable experience, both in the public and private sectors”, said Christian Ducron, Information Systems Consultant at Carestream Health in France. “Each deployment has given us the opportunity to further develop our Cloud solution, especially in the area of data sharing, and we fully understand and can respond to the challenges involved.” Mr. Christian Blanchetière, Director of the MIRC project at the GCS TéléSanté Centre, said, “TéléSanté Centre is made up of a central buying department which manages the TéléSanté Centre project. The competitive dialogue, in which numerous public and private professionals participated, allowed a general consensus to be obtained on the expected features and costs. This project will also benefit the accredited professions, notably the consultants and specialists who can access their patients’ medical images quickly and simply. We are looking forward to a rapid deployment.” Carestream Rochester, NY, USA www.carestream.com UK hospital trust goes for Agfa DR upgrade The North Tees and Hartlepool Hospital Trust in the north east of England has implemented Agfa HealthCare’s affordable and versatile direct radiography (DR) upgrade solution. This upgrades the Trust’s previous CR system to a wireless DR system, maximizing existing investment in imaging equipment. The upgrade involved a quick and easy installation that required minimal training. The new system provides excellent MUSICA image quality, fast previews, low cycle times and smooth integration with radiology and other hospital-wide information systems. Immediate benefits have been found, particularly in the hospital’s Chest Clinic, with significantly increased patient throughput whilst retaining high image quality. Darren Smith, PACS Manager at the Trust, commented: “The DX-D Retrofits are being used in two new Siemens general purpose x-ray rooms and APRIL/MAY 2014

an existing Philips Chest Clinic. These rooms were CR only and by adding Agfa HealthCare’s DX-D Retrofit solutions we now have the workflow and image quality benefits of DR. We’ve also seen immediate benefits, especially in the Chest Clinic with significantly increased patient throughput whilst retaining high image quality. In addition, the wireless capabilities offer convenience and portability, which is a huge benefit in a busy hospital. Our staff also found the system very intuitive so additional training was kept to a minimum.” Demographic data is automatically fed to the NX workstation from the PACS, and acquired images are transmitted directly onto the detector, streamlining workflow and speed of exams. Within seconds after the acquisition, radiographers can pre-check the image, approve the technical quality and transmit it wirelessly to the PACS. The detector fits into any standard bucky tray and can be used in multiple X-ray modalities, meaning it can be shared among several rooms or modalities as needed, maximizing efficiency and keeping costs low. Agfa Healthcare Mortsel, Belgium www.agfahealthcare.com Grant given for development of low-cost 3D healthcare scanner UK-based Fuel 3D Technologies has announced it has secured a $1.1 million grant from the UK’ s Small Business Research Initiative (SBRI) for Healthcare for the development

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of a 3D medical imaging system. The company has already developed the Eykona Wound Measurement System which generates 3D images of wounds to allow objective measurement for accurate wound assessment. Fast processing enables rapid display of interactive 3D images and helps support an evidence-based approach to wound care, wound characterization and management. Stuart Mead, CEO, said that the aim of the new SBRI grant is to develop the Eykona system into a general medical scanning device able to benefit more patients in more specialties. Fuel 3d Chinnor, Oxon UK www.fuel-3d.com EuroSafe Imaging campaign launched The demand for medical imaging examinations is constantly growing, and safety and quality are more important than ever for the good use of radiology. The European Society of Radiology (ESR) has taken a major step in this direction with the official launch of its EuroSafe Imaging campaign during the recent ECR meeting.

The new campaign, which brings together many stakeholders, will strengthen medical radiation protection across Europe following a holistic approach, according to ESR President, Prof. Guy Frija from Paris, France. “The campaign focuses on promoting appropriateness in medical imaging, maintaining doses within diagnostic reference levels and emphasising the need to promote the use of up-to-date equipment,” he said. The need to support the implementation of European Directives on medical radiation protection has never been greater than today with 35


Industry NEWS patient radiation exposure rising, according to the ESR’s Chairman of the Radiation Protection Subcommittee, Prof. Peter Vock from Spiegel, Switzerland. EuroSafe Imaging is a campaign designed to meet the needs of the present, he said. The purpose is to promote the appropriate and safe use of imaging, as well as the utilisation of features in dose efficient equipment, through cooperation with stakeholders to ensure a multidisciplinary and holistic approach to radiation protection. EuroSafe Imaging is run by a steering committee, which is composed of delegates from the ESR, subspecialty societies, related medical professions, patient groups, and the industry, along with an observer from the European Commission. Patient groups play a key role in the campaign, as patient communication on radiation protection is one of its major objectives. ESR EuroSafe Imaging Vienna, Austria, www.eurosafeimaging.org Installation started of world’s first high-field MRI-guided radiation therapy system The initial components of the world’s first high-field magnetic resonance imaging (MRI) guided

The first component – the system’s ring gantry on which linac parts are mounted – was lowered by crane through a modular roof into one of UMC Utrecht’s radiotherapy treatment rooms. In the coming months, additional components will be integrated and the system will undergo a program of non-clinical testing, which includes the performance evaluation of MRI sequences, testing of different adaptive delivery methods, establishing quality assurance techniques and defining workflow.

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radiation therapy system are being installed at the University Medical Center (UMC) in Utrecht, The Netherlands. This is the first step toward the development of a clinical system capable of capturing highly detailed MR images of tumors and surrounding normal tissues as a patient receives radiotherapy. Development of the high-field MRI-guided linear accelerator is the mission of the MR Linac Research Consortium headed by the Swedish company Elekta and supported by Philips. The integration of an advanced Philips 1.5 Tesla MRI system with a sophisticated Elekta radiation therapy system – enabling simultaneous imaging during beam delivery – should help adaptation of radiation therapy during the procedure, increasing treatment accuracy, potentially reducing side effects and enabling increases in the therapeutic dose. “Since formation of the consortium in 2012, members have been exploring the feasibility of high-field MRI-guided radiotherapy. Installation of the first generation system is truly a major step toward moving this technology into the clinic to benefit patients” says Dr Bas Raaymakers, Associate Professor, Department of Radiotherapy, UMC Utrecht. “We’re immensely proud of the critical role that UMC Utrecht has played in collaboration with Philips and Elekta in this project for over 10 years.” “As the founding member of the consortium, UMC Utrecht has been instrumental in turning the concept of MRI guided radiation therapy into a working system, and has invested a great deal of effort and resources to make it a reality” adds Tomas Puusepp, President and CEO, Elekta. In addition to UMC Utrecht, the other consortium members are: The University of Texas MD Anderson Cancer Center (Houston, Texas), The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (Amsterdam, the Netherlands), Sunnybrook Health Sciences Centre (Toronto, Ontario) and Froedtert & Medical College of Wisconsin Cancer Center (Milwaukee, Wisconsin). D I

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Philips Eindhoven, The Netherlands www.healthcare.philips.com Elekta, Stockholm, Sweden www.elekta.com Football club opens State-of-the-art medical imaging suite Manchester United and Toshiba Medical Systems have opened a brand new medical facility at the football club’s AON Training Complex. The collaboration will promote the rapid development of novel sports medicine and exercise-related applications for CT, ultrasound and MRI scanner technology developed by global leaders in the fields of football and medical technology. The technology will enable Manchester United’s medical team in partnership with Toshiba Medical Systems team to push the boundaries of sports medicine with regards to optimization of diagnosis, rehabilitation and preventative care.

With the ultimate aim of maximising the wellbeing and safety of players by means of enhanced musculoskeletal, cardiac and general health screening, the collaboration will undertake studies into early markers of potentially preventable injuries and ways of maintaining player career longevity at elite level. By using imaging in innovative ways to track the physical and physiological development of footballers, the partnership will result in further refinement of personalized treatment and exercise regimes for individual athletes, from youth academy to first team. Toshiba Zoetermeer, The Netherlands www.toshiba-medical.eu 37


Company profile A start-up spreads its wings Although it is not even ten years old, the UK-based startup company Michelson Diagnostics is already making a big name for itself through its patented advanced imaging technology, Optical Coherence Tomography (OCT). Able to provide ultrahigh resolution images of just about every epithelial tissue in the body, OCT has many applications. For the moment Michelson Diagnostics is focussing on dermatology, where promising results are being generated in clinical trials. We wanted to know what makes Michelson Diagnostics tick and where the company is headed, so we spoke to Jon Holmes, CEO of the company.

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. Michelson Diagnostics is about eight years old. Whatâ&#x20AC;&#x2122;s the story behind its creation? Yes it seems like yesterday but in fact it was in 2006 that, with a couple of colleagues, we founded Michelson Diagnostics. Our backgrounds and expertise were in industrial applications of laser scanning and image processing, principally in the world of factory automation. For example, we used advanced technological approaches in applications such as automatic quality control and inspection of products as diverse as silicon chips and plate glass. On the face of it, therefore, a field that seems far from the medical imaging area where we are now active. However I really saw an opportunity to apply our expertise in scanning technologies to the biomedical field and came across this wonderful field of Optical Coherence Technology (OCT), which was a perfect match between our skill sets and the clinical need of high resolution images of sub-surface objects. We could see that there was a gap in terms of image quality and came up with an idea to address that image quality gap. OCT still underpins our company, and is our unique technology, albeit one with many, many clinical applications.

Q

. Well before we go much further maybe youâ&#x20AC;&#x2122;d better give a short description of the OCT technique itself and the principles behind it. Originally developed by Prof Fujimoto in MIT as far back as the early 1990s, OCT is an optical signal acquisition and processing method, founded on the wellknown physical principles of optical interferometry. OCT enables the generation of 3D images of very high resolution â&#x20AC;&#x201D; at the micrometer level, that is some 10 to 20 times higher resolution than typical ultrasound images. A trade-off with respect to the extremely high resolution is the fact that the penetration in the tissue being imaged is only a few millimeters. (Although various tricks can be used to squeeze some more depth of image, this always comes at the price of lower resolution). The low penetration of the technique means that it is

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With a background in industrial applications of laser scanning and image processing, Jon Holmes is a co-founder of MIchelson Diagnostics and has been CEO since its creation in 2006. Since then, Jon has successfully piloted the company through several financing rounds and the associated milestones.

mainly suitable for examination of epithelial surfaces. Indeed one of the first applications of OCT was in the analysis of the surface of the retina. Literally tens of millions of cases have by now been scanned with OCT. The method has become almost the technique of choice in the analysis of several eye diseases and is used on a global basis to make clinical decisions regarding blinding diseases such as macular degeneration, diabetic retinopahy and glaucoma.

Q

. If OCT is already well established, what does Michelson Diagnostics bring to the party? We bring our proprietary variant of the method which is the use of multi-beam as opposed to single-beam technology. In our implementation we use four separate beams of laser light, each of which is focussed at a different depth. These are then scanned separately and a compound mosaic image generated. With our multi-beam technology, which was originally developed by Prof Yang from the University of Toronto in Canada, we get even higher resolution (in fact twice) than with single beams. We use a sophisticated diode laser operating at 1300 nm, i.e. in the Near Infrared Region. We have a rapid wavelength sweep at 20 000 times per second on either side of the central 1300 nm wavelength, from 1250 nm to 1350 nm. This approach is one that is used regularly in the telecommunications industry for the monitoring of the quality of fiber-optic cables. This makes the whole approach more affordable.

The high resolution of the images generated by OCT enables dermatologists to identify architectural features in the tissue layers just under the skin surface. In many cases this obviates the need for taking skin biopsies.

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The high resolution of the images generated by OCT enables dermatologists to identify architectural features in the tissue layers just under the skin surface. In many cases this obviates the need for taking skin biopsies.

Q

. Is this high resolution really needed clinically? The straight answer to that is yes. Of course as I said there are many potential applications of OCT each with their own particularities, but in the one that we have decided to focus on, namely the analysis of skin cancers such as non melanoma skin cancer (NMSC), the higher the resolution the better. This is so that the dermatologist can identify the critical morphological features of the tissue underlying the skin.

Q

. You mentioned that you have decided to focus on dermatological applications. Why? It’s true that there are many more possible applications of OCT than in the analysis of dermatological cancers. I’ve already mentioned the well-established ophthalmological applications, but there are many others, such as measurement of atherosclerotic plaque in the coronary arteries, analysis of oral cancers, etc. — by the way the potential of OCT in imaging oral cancers seems especially interesting. But back to dermatology. This area seems particularly intresting to us since there is an ever-increasing number of patients with suspect lesions needing to be analyzed to determine whether they are malignant or not. Epidemiologically the increase in the number of NMSC cases is probably due to the aging of the once “golden” generation of the baby boomers who exposed themselves immoderately to the sun. The cumulative effect over time of many hours of exposure to sunshine with no skin protection is certainly partly responsible for the current huge increase in the number of cases. Although the deadly malignant melanoma gets a lot of the headlines, in fact there are nearly twenty times more cases of non-melanoma skin cancer (NMSC) . The clinical priority is to determine as reliably as possible whether the lesion is malignant or not. For this, the gold standard is biopsy/histology. Apart from the obvious discomfort for the patient, the biopsy approach is time-consuming and costly, all the more so when there are many lesions to be looked at. In contrast, OCT, through use of a small hand-held optical scanner, generates immediately high quality and high resolution images of the sub-dermal tissue micro-structure, Thus it is quick and painless to the patient.

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And then if after confirmation that the lesion is indeed malignant, the monitoring of the subsequent surgical procedures can also be significantly improved by use of OCT technology. In cases of malignant skin cancers, the aim is to excise the malignancy as completely as possible, with excision of as little as possible of the surrounding normal tissue. Frequently, to be as sure as possible that all cancerous cells are removed the excision area is made as large as possible, with the consequent disadvantage that a cosmetically disfiguring scar on normal tissue remains. An alternative is the so-called Mohs approach, which is often used to treat common types of skin cancers, especially in the United States. Basically the procedure is a microscopically controlled surgery, during which, after each removal of tissue, and while the patient waits, a pathologist examines the tissue specimen there and then for cancer cells. The results of this histology examination inform the surgeon where next to remove tissue. Although the success rate is generally high, the obvious downside is that, depending on how many iterations are involved, the procedure can take a long time. It is clear that a rapid analysis by OCT of the cellular structure of the remaining tissue has the potential of saving a significant amount of time. The approach has several advantages, such as being quick and painless, being able to immediately determine whether the lesion is shallow enough to be treated by non-invasive mans such as creams. In addition the response of the lesion to the treatment can be easily monitored.

Q

. I n practice how are your evaluations of the technique in dermatology getting on? These are going well. The OCT instrument that we have developed Vivosight OCT was selected for use in a recently completed multi-centre, prospective clinical trial for the diagnosis of basal cell carcinoma. In the study, over 250 patients with clinically suspicious lesions for basal cell carcinoma were scanned at six centres in Germany. In each case, diagnosis using VivoSight OCT was compared

Designed for easy disinfection, the probe is comfortable both for the clinician and the patient.

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Company profile

The Vivosight system produced by Michelson Diagnostics.

with the gold standard of biopsy and histological analysis. The clinicians involved in the trial, Prof J Welzel, and Dr M Ulrich have just presented the results at the recent American Acacademy of Dermatology’s annual meeting. Dr Ulrich concluded in her presentation that: “VivoSight enabled a statistically significant improvement in the specificity and Negative Predictive Value (NPV) of Basal Cell Carcinoma diagnosis over both clinical and dermoscopy on this cohort of challenging pink patches. Thus many biopsies can be avoided with VivoSight OCT, and patients can instead be treated non-invasively.” The full data will be published later this year, but already we are encouraged that the preliminary results support our contention that OCT can be used to significantly reduce the need for biopsies. More broadly we believe that our system has the potential to become the standard of care for the non-invasive diagnosis and monitoring of certain diseases and conditions that affect the skin, and in particular non-melanoma skin cancers.

als that are being carried out on your system. What about funding? regulatory issues? Reimbursement? Yes we have to keep our feet on the ground in the midst of these exciting results. We are still a small start-up, albeit one with highly qualified people on board. We have a total head-count of 19, most of whom are based in our facilities in Orpington, Kent in southern England. In addition we have sales offices in Munich, Germany and also in the United States. ‘Regarding regulatory status, our Vivosight system has the CE mark and 510 (k) clearance in the United States. It is also registered with TGA in Australia.’. Our major marketing focus is at the moment on Germany, United States and in Australia. Regarding re-imbursement, the technique is already re-imbursed in Germany for patients within the private health insurance system. As for financing, so far we have successfully negotiated several funding rounds, mainly from venture capital companies and have met the associated deadlines. In addition to all this we were recently awarded a EUR 2.3 million grant from the EU under the EU’s framework programme. This was for a collaborative development project — known as Advance (Automatic Detection of

VAscular Networks for Cancer Evaluation) in which Michelson Diagnostics is the lead partner. The aim of the three-year project is to use OCT technology to determine the extent of vascular networks underlying certain skin cancers. The hope is that the measurement of such vascular networks could be an early indication of malignancy. Since OCT is the first technology available that can visualize the 3D vascular network in and around the skin tumors within the tissue, in vivo and in real time the device should enable not just the identification of the tumor but also its stage of development and aggressiveness.

Looking further down the road, we recognise that, as we accumulate more and more data from clinicalQualify trials sup-for your porting the use of OCTFREE technology, we subscription t will have to expand our marketing and Diagnostic Imaging Euro support infrastructure. One way to do this could be via arrangements under 1. Fill out this form, answeri which we would license our technology all questions – and be su to the well-established medical imaging to include your signature. companies, who up until now do not have OCT as one of their2.main Emailimaging to : info@dieurope.co modalities. But that’s for the future. In the mean3. the Enjoyexciting your FREE time we are dealing with subscription to present. Diagnostic Imaging Europ

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T EC HN OLOGY update Entry level CT with low operating costs

The new Somatom Scope CT system from Siemens is a 16-slice CT scanner designed for the entry-level segment of the marjet and offers remarkably efficient operating costs over the entire operational lifetime – up to 35% lower than with the previous model. The new CT scanner is available in two configurations: the particularly cost-effective Somatom Scope and the higher-performance Somatom Scope Power. Both models include the eCockpit technology package, which makes the systems easier to use and extends their operational lifetime. Several factors are responsible for the noticeable reduction in overall operating costs, beginning with the very low space requirement of just eight square meters and the light weight of the new CT scanner. This means that it can be installed in almost any room with little inconvenience. Energy consumption also plays an important role throughout the entire lifespan. Several energysaving functions not only reduce the energy required by both Somatom Scope configurations, but also save on air conditioning due to low heat emissions. Energy savings of up to 65% can be made compared with the previous generation. The eCockpit technology package helps to further reduce energy costs through its eSleep function, which puts the gantry in sleep mode if it is not used for an extended period. In addition to eSleep, other innovative technologies, namely eMode and eStart of the eCockpit have been incorporated to the entry-level market for routine scanners. eMode automatically selects the optimum scan parameters to reduce wear and 42

Total dose management system The new Radimetrics Enterprise Platform from Bayer Healthcare is the industry’s first software solution to address Total Dose Management. The platform provides real time analytics for radiation dose management and contrast dose management through a single point of access. It supports radiation exposure data collection and analytics from multiple imaging modalities and is compatible with the Certegra Point of Care solution for display of patient contrast dose information. (Interfacing with Bayer’s Medrad Stellant CT Injection Systems, the Certegra Point of Care solution is an informatics-driven, touch‐screen hub that enables time savings and optimizes protocols which may enhance patient care through a powerful suite of CT contrast dose management applications. This comprehensive suite of software options provides healthcare professionals instant access to real-time actionable CT contrast data captured at the point-of-care). The Innovative Radimetrics Enterprise Platform will give radiology professionals a single interface with tools to manage radiation and contrast dose. It enables data access at every step of the imaging workflow supporting clinical decision making and automates documentation of contrast and radiation dose. The software provides dosimetry information and tools throughout the entire radiology workflow and thus supports ordering physicians, radiologists, technologists, clinical physicists, radiation safety officers and hospital administration. Radimetrics Enterprise Platform has an extensive set of features that can be used by the radiology professional to support patient safety initiatives, regulatory reporting, quality assurance, accreditation and utilization management. “Patient awareness is dramatically increasing and we think it is absolutely necessary to monitor radiation doses. Each day, our task is to reduce that dose and optimize our scanning protocols,” said Prof. Michael Forsting, Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, Essen, Germany. “With Radimetrics we can now create certain sheets with protocols that allow us to see when radiation exceeds defined limits or, if there has been a protocol violation.” Bayer Healthcare Berlin, Germany http://healthcare.bayer.com tear on the scanner hardware, thus making the device more efficient and reducing maintenance costs and device downtimes while maintaining the correct balance between radiation dose and image quality. In addition, eStart enables extension of lifespan of the X-ray tube – one of the most expensive CT components – by a dedicated warm-up procedure before the first scan after longer periods in stand-by to protect the tube material. Siemens Erlangen, Germany www.siemens.com D I

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New generation of image processing software

Agfa HealthCare has launched the next generation of its gold-standard MUSICA (Multi-Scale Image Contrast Amplification) image processing software in Europe. New technology improvements such as Fractional Multiscale Processing enhance both image quality and workflow for radiographers and radiologists. The improvements will support radiologists to get the most out of images at a lower dose. The latest generation of MUSICA offers all the benefits of previous generations, including consistently high image quality across all of Agfa HealthCare’s digital radiography APRIL/MAY 2014


solutions and robustness against variations including patient size, tube quality and exposure settings. Workflow improvements include the elimination of the need for window level adjustment, for even easier and faster image reading. Radiologists also get more diagnostic information from their images, with a high level of detail in the mediastinum, sharp trabecular and cortical bone, a balanced presentation of 2/3 both soft tissue and overlapping bone structures, visualization of subtle details in the abdomen, and a true representation of implants with clear bone interfaces.

Fractional Multiscale Processing (FMP) makes it easier to see and distinguish the subtle details in images, meaning “the diagnosis is in the details”. The balanced presentation of all tissue structures, from bone to soft tissue, results in images that are very comfortable to read. MUSICA enhances productivity for both radiologists and radiographers, offering a streamlined workflow. All of the parameters needed are derived or calculated by MUSICA from the input image itself. This automatic analysis of the characteristics of each image and optimization of the processing parameters saves time and effort. To support optimal image quality while protecting people in X-ray environments, Agfa HealthCare integrates the ALARA (As Low As Reasonably Achievable) principle in its product design. A key goal is to provide users with consistently high image quality across all exams and all patients at all hospitals, with a minimal radiation dose. Along with the development of high DQE (Detective Quantum Efficiency) DX-D Cesium detectors, the NX Exposure Index to avoid dose creep, and IMPAX REM for an overall dose radiation exposure management, this new version of MUSICA is an important step in Agfa HealthCare’s continuing efforts to further increase image quality while giving hospitals tools to manage patient dose.

Innovative contrast agent injector The new FlowSens system from Guerbet is an innovative solution for the injection of contrast agents and saline solution in CT imaging. It includes a dual soft bag injector (class IIb, CE marked), a complete range of associated disposables (class IIa, CE marked) and services. The injector is adapted to single or multi-patient markets, mono or bi-liquid uses. It is available in pedestal or ceilingmounted versions. Presented for the first time at the recent ECR meeting this unique, innovative solution enables Guerbet to broaden its range in the field of medical equipment and devices for diagnostic imaging market. CE Marked in the first quarter of 2014, FlowSens will initially be marketed in Europe (first in Belgium, France, Germany, Switzerland) then gradually in other regions of the world. FlowSens and its associated disposables are designed to fit seamlessly into the organization of radiology services. Ergonomic and easy-to-use, FlowSens aims at meeting the practical requirements of radiologists and radiographers. Composed of a soft bag injector, a complete range of associated disposables and services, the FlowSens solution is the only one on the market which combines a hydraulic syringe-free injection system with intuitive usage and safeguarding of procedures at every stage of the injection. FlowSens is compatible with ScanBag and all types of contrast agent available on the market. Guerbet Group CEO Yves L’Epine declared “We are very pleased to make available to radiology professionals a contrast agent injection solution which is the only one of its type in the world, developed in France by the Guerbet Group subsidiary Medex. This launch is in line with the Guerbet Group’s strategy of diversification into medical devices linked to the use of our contrast agents for diagnostic and/or interventional radiology”. FlowSens targets a market segment with high growth potential. Its syringefree hydraulic injection system and its clear advantages distinguish it from the existing competitors’ offering (syringe & peristaltic based systems). Guerbet, Villepinte, France www.guerbet.com www.flowsens.com

Rapid upgrade to DR

A new upgrade system from Canon enables the benefits of DR to be obtained in less than two minutes. Only two components — a portable DR workstation and a Canon flat panel detector — are

Agfa Healthcare Mortsel, Belgium www.agfahealthcare.com APRIL/MAY 2014

required to provide DR with any existing X-ray system. Lightweight and battery powered, the flat panel detector provides wireless freedom in a large size format. No connections or modifications are necessary to the existing X-ray system. The upgrades are not tied to any X-ray system; they can be simply picked up and moved to another. There is an option for integrated USB DAP Meter. Canon Medical Systems, Amstelveen, The Netherlands www.canon-europe.com/Medical/

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Spotlight: Innovation and the Heart

Discover the Scientific Programme www.escardio.org/ESC2014programme

â&#x20AC;˘ Early Registration deadline : â&#x20AC;˘ Late Registration deadline :

5 days of scientific Sessions 150 CV Topics 30 000 healthcare professionals from 140 countries 11 400+ abstracts submitted 500 expert sessions 200 exhibiting companies & all year long on ESC Congress 365

31 May 31 July


TECHNOLOGY update Low-cost whole-body CT system

New line of ultrasound scanners

The Astelion Advance system from Toshiba is a new low-cost whole-body CT system for customers who require high patient through-put, advanced 3D and post processing applications and who also demand the latest in dose reduction technologies. The new system is the only entry level multislice CT system in the industry offering the same superb iterative reconstruction technique (AIDR 3D) as implemented in Toshiba’s elite CT systems, namely Aquilion ONE ViSION. The integration of AIDR 3D into SUREExposure 3D controls means that radiation exposure is automatically reduced before the scan, ensuring the lowest possible dose for the specific diagnostic objective, irrespective of the size or shape of the patient. AIDR 3D can be applied to all acquisition modes for routine clinical use and is able to remove up to 50% of image noise, which corresponds to a dose reduction of up to 75%. The new compact CT system also features Toshiba’s exclusive, industryleading Quantum Detector technology and the 16 row Astelion Advance Edition incorporates 0.5 mm detector technology for acquiring true isotropic voxels. The 0.5 mm detector elements (the smallest in current CT technology) provide razorsharp images, ensuring fast and accurate diagnosis in all parts of the body with a lower exposure dose. Featuring navigation-guided scanning, Astelion Advance Edition is designed for operators of all levels of experience. Using unique “Double Slice Technology”, initially developed for the 320-row Aquilion ONE, the Astelion Advance Edition is capable of generating 32 axial slices in a single rotation using for outstanding spatial resolution and extended flexibility. Toshiba Medical Systems Europe Zoetermeer, Netherlands www.toshiba-medical.eu APRIL/MAY 2014

With more than sixty years’ combined experience and know-how in imaging techniques, Hitachi and Aloka have always been pioneers in the development of reliable high-quality solutions for a broad range of ultrasound applications. The company has now introduced the ARIETTA 70 and ARIETTA 60 models which are two new diagnostic ultrasound platforms combining the know-how developed in the HI VISION series of Hitachi Medical Corporation with the ProSound models of Aloka Co. as well as the results coming from a close collaboration involving the Central Research Laboratory of Hitachi, Ltd. Though requiring very little space, the new ultrasound platforms give highly resolved ultrasound anatomical detail thanks to the newly optimised generation, emission and detection of ultrasound signals, the improved signal processing, as well as the superb quality of the display. Using multi-layer crystal technology and an improved connector, the versatile range of probes achieves very high sensitivities from the enhanced signal-to-noise ratios, in addition to improved durability and handling. The sophisticated, flexible programming of the emitted and received ultrasound signals allows more precise control of the ultrasound beam, guaranteeing higher spatial resolution. Additionally, the new platforms are equipped with fast ultrasoundspecific digital signal processors, supporting a great variety of applicationrelated features and advanced data processing. In combination with the wide view angle and the excellent contrast

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of the IPS- Pro monitor, this powerful signal processing unit significantly enhances image clarity. The new ultrasound products ARIETTA 70 and ARIETTA 60 are ideally suited for many advanced applications, such as Real-time Virtual Sonography for a side-by-side display of ultrasound and results from other modalities, e. g. CT or MRI; Real-time Tissue Elastography, visualising tissue strain in realtime and giving local stiffness information; 2D-Tissue Tracking for quantitatively evaluating the movement and the thickening of the cardiac muscle. To help the user produce the high

quality diagnostic images, the new systems incorporate features that reduce stress and improve ease-of-use. Detailed ergonomic design. For example, compared to previous models the new systems are 45 % lighter. Two-way multirotary encoders enable the adjustment of many functions in one control, thus significantly reducing hand and arm movements. The large palm rest at the center of the operating console is designed to give optimum wrist support and the panel height can be lowered to 70 cm, allowing the operator to perform lower extremity examinations with a safe, comfortable reach to the operating console. Hitachi Medical Systems Europe Zug, Switzerland www.hitachi-aloka.co.jp. www.hitachi-medical-systems.eu.

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TECHNOLOGY update Dose Management Solution

Handheld real-time personal ultrasound system

Utilizing a comprehensive approach encompassing leadership, practices, and technology, GE Blueprint helps healthcare organizations build a strategic roadmap for a comprehensive radiation dose management strategy that goes beyond dose technique and technology. The system offers several features, such as a Dose Education Portfolio, which offers multiple ways to provide staff training, from radiation safety training to protocol optimization and technologist dose knowledge assessment. The Benchmark feature provides a way to obtain a comparative performance baseline of dose management efforts and the Customer Communication Package helps customers communicate dose management practices to referrals/prescribers, payers, regulators, and patients. GE Healthcare Chalfont St GIles, Bucks, UK. www.gehealthcare.com

Digital MRI

Philips has expanded its digital MR offering to meet local market needs with the launch of the Ingenia CX, which is available both in 1.5T and 3.0T. Ingenia is the firstever digital broadband MR solution and delivers a new standard in image clarity, scanning efficiency and scalability digital broadband MR: Signals are digitized at the radiofrequency level and then transmitted to the reconstruction engine via fiber-optic cable, so ensuring the delivery of highquality data without the signal loss that can occur on conventional MRI scanners The new systems are based on the company’s unique dStream architecture that delivers

The Signos RT system, developed and manufactured in Adelaide, South Australia by Signostics, is the company’s second generation portable handheld ultrasound device, utilising cuttingedge technology to give users the critical ability to view ultrasound images in real time. The world’s smallest and most affordable completely portable ultrasound system, Signos RT features unique patented technology and an award winning design to provide a completely portable, lightweight, hand-held ultrasound device for point-of-care use by medical personnel in a number of clinical settings. These include primary care, rural and remote, maternity and midwifery, bladder scanning, emergency and intensive care. It is also suitable for a wide range of veterinary applications, primarily aimed at companion animals.

Clarification.

In the March 2014 issue of Diagnostic Imaging Europe we ran a Technology update piece on the hand-held ultrasound system which is marketed in the United States by Konica Minolta under the brand name Sonimage P3. This arrangement only applies to the United States. In Europe, the hand-held ultrasound system is exclusively marketed by the manufacturers, Signostics, under the brand name Signos RT. DI Europe apologises for any confusion caused. premium Image quality with digital clarity and speed. Other features are include the MuliTransmit 4D system which enables enhanced contrast, uniformity and consistency in challenging applications at 3T. iPatient provides fast, comfortable patient setup – even for challenging patients – and

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The pocket-sized ultrasound device, often worn around the neck like a stethoscope, offers real-time imaging capabilities for quick and simple point of care applications such as e-FAST scans, pneumothoraces, AAA screening, bladder volumes, basic pregnancy assessments and ruling in obvious pathology. The system helps medical practitioners to visually assess a patient at the point-ofcare more efficiently than ever before and rapidly produces high resolution images to assist clinicians in assessing patients and improving health at a price much more affordable than conventional cart-based and portable ultrasound systems available in the market today. With its Head Office in Adelaide, South Australia, where it was established in 2005, and offices in Palo Alto, California, Signostics Limited is an international medical device company with a vision to be the world leader in providing clinicians with small, fast and affordable handheld tools for use at the pointof-care. Signostics launched its first generation Signostics Adelaide Australia www.signosticsmedical.com

D I

E U R O P E

supports high quality reproducible results through patient-centric imaging. The Ingenia CX features a 60cm bore. Philips Eindhoven, Netherlands www.healthcare.philips.com APRIL/MAY 2014


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Dieurope AprilMay2014  

DIEurope is the only dedicated magazine focusing on information for the EMEA Radiologists

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