VIENNA – The accent was on the soft side this year at the annual congress of the European Society of Radiology.
Heavy metal hardware has held the spotlight but increasingly today it is software that moves markets and purchasing decisions.
In CT for example, recent years have seen a fierce competition as competitors boosted power of projectors, built ever wider arrays of detectors and pushed faster gantry speeds.
Suddenly this year the lead product feature is software for iterative reconstruction that boosts image quality for acquisitions at low-radiation doses.
An survey of CT specialists in January revealed that 92% consider dose reduction capabilities as the most important feature they seek in new CT equipment.
Processors, and not power, increasingly influence the choice of ultrasound and MRI scanners, two modalities with signals that lend themselves to digital wizardry on computer workstations.
As tubes, transducers and teslas fade to the background, the limelight is now shared by PACS and workflow management systems.
Scanning the exhibition floor at a congress, radiologists today wonder aloud whether they have mistakenly wandered into an IT exposition given the prominence of information systems that speed exams, enhance picture quality or manage the massive archives of digital images.
Philips Healthcare (Eindhoven, the Netherlands) is unbashed this year at ECR2011, ripping a page from the IT manual for its product theme, “Imaging 2.0,“ which includes promotional claims such as “the first-ever Digital Broadband MRI System.“
'The radiology report is a hyperlink'
The president of this year's congress, Yves Menu, MD, said he came on line with a PACS system five years ago at Saint Antoine Hospital (Paris).
“Now I have trouble remembering how we worked without it,“ he told BB&T.
During the same period the number of images per exam has grow exponentially.
“There are thousands of images for every exam, so that even the idea of an 'image' no longer exists,“ he said.
“A single image does not mean anything by itself, it is nothing more than a letter in an alphabet,“ said Menu. “These letters form words and then sentences, but they no longer have a value alone.“
He said the traditional radiology report with selected images as a fixed object for viewing no longer makes sense.
“The radiology report today is a hypertext link to a series of images tagging segments,“ he said, explaining the segment selected for study is actually a volume acquisition, a multimedia document that allows a reader to move through slices.
Cardiac imaging challenges reflex to stent
“Just a few years ago there was not a cardiology session at ECR, and now there is a tremendous number of submissions to the congress,“ according to Christian Loewe, MD, from the Medical University Vienna.
Loewe shared the podium during a scientific session at ECR with Marco Francone with the Sapienza University of Rome to report on their investigations into the topic, “MRI and CT before cardiac interventions or surgery.“
The introduction of advanced capabilities with multi-detector CT (MDCT) and contrast enhancment techniques for MRI are making a strong contribution to imaging of the heart that previously relied upon two-dimensional, grayscale angiography.
Retrospective studies using these emerging techniques for the structural and functional assessment of coronary artery disease (CAD) are adding considerable weight to a clinical challenge that has slowed the rapid adoption of revascularization of coronary arteries through percutaneous coronary intervention (PCI).
The question now being studied is whether MDCT and MRI techniques can predict the outcome of cardiac interventions before the stents are placed.
“Just because we can revascularize does not mean we should in all cases,“ said Loewe.
“CT can clarify which lesions should be treated and which should be left alone,“ he added, explaining that it is increasingly possible to identify by various parameters the 'culprit lesion' that places a patient at risk.
“In the future there is the potential to personalize treatment with CT so that the patient is not carrying unnecessary stents,“ he said.
According to Francone, interventional cardiologists increasingly recognize that “when they implant a stent, they are implanting a new disease, because after a number of years that stent becomes closed again by restenosis.“
With MRI the examination of the heart moves from the coronary arteries, where CT has advantages, to the myocardium, the muscular tissue of the heart.
MRI offers an ability to characterize tissue that is 60 times greater than molecular, or nuclear imaging, he said.
The focus is assessing patients with continuing and chronic coronary artery disease who are non-acute.
High risk, narrow markets stunting growth for MDx
The bubble of hype surrounding molecular diagnostics (MDx) has burst, leaving Fabian Kiessling, MD, a lone voice still preaching its promise at ECR.
The Chair for Experimental Molecular Imaging at the University of Aachen (Germany), Kiessling said his colleagues in radiology “see us as some kind of strange scientists in the basement, these mouse doctors, researching things that sound very interesting but are too complex to translate to the clinic.“
At ECR, Kiessling separated fact from fiction in MDx during two sessions, one with the hopeful title, “Molecular Diagnostics Made Easy,“ and a second tracing the barriers for the development path, “Molecular Imaging from Bench To Bedside.“
Worse for the reputation of MDx, he said, is that once a successful technique is adopted into routine practice in the clinic, it is no longer recognized as a molecular imaging tool.
Beyond the widely, and some would say wildly, used PET for CT, there are liver contrast agents used in MRI and then MR spectroscopy.
A real fact in the nascent MDx field, he said, are new techniques and probes coming online in the next few years.
Closest to the clinic are contrast agents for ultrasound that illuminate processes like new blood vessel creation by tumors thanks to bubbles injected into vascular systems.
Furthest from the clinic, however, are the magical compounds everyone expected would quickly create a highly personalized medicine by targeting small pre-cancerous lesions and nipping them in the bud, or the idea that a single diseased cell in the body could be routinely spotted and zapped.
Forgetting for the moment these fictions of science, “there are thousands of new probes in the wings and a next generation of radiopharmaceutical tracers,“ he said.
“But the pharmaceutical industry is hesitant to bring these new probes to market because of the high risk and narrow market opportunities,“ he told BB&T in an interview.
“On one hand the development of diagnostic agents is very cost-intensive, in the range of $300 million to $600 million,“ he said.
“Yet developing an agent presents even more complex issues than drug development, because in principle, a diagnostic agent for a cancer, for example, needs to be more safe to administer than a chemotherapy to treat the cancer,“ he said.
Regulatory agencies are willing to tolerate higher levels of toxicity for cancer therapies as these will be administered to patients with a limited life expectancy, patients who are not likely to experience the longer terms effects, he explained.
“But a diagnostic agent is being administering to healthy patients to determine which of them is ill, which means we need to consider that at least 60% of these patients are not and will have a normal life expectancy,“ he said.
Except for the potential effects of the toxicity of a contrast agent, which sooner or later accumulates in the liver.
This increases the cost of developing diagnostic probes and makes an agreement to use them complex.
Logistics for sensitive contrast agents can also create present challenges for a manufacturer that add to costs.
“Consider a radiopharmaceutical with a half life of two hours,“ suggests Kiessling.
Here the source of the agent for the customer must be a local cyclotron.
Similar logistics can challenge other highly perishable or delicate diagnostic agents.
After clearing regulatory hurdles and plotting an appropriate distribution strategy, a new molecular diagnostic agent must then cross a forbidding financial landscape.
Here straightforward economics are at play.
“People are willing to pay much more for treating a disease than they are for diagnosing the disease,“ he said, which reduces the market reward for the manufacturer of a diagnostic agent.
“Finally, the more specific and highly targeted a diagnostic agent, the smaller the potential patient population will be by definition, which again reduces the market reward for a pharmaceutical company.
All disease is cellular
In the face of these obstacles, there is an inevitability to further development of molecular diagnostics.
The blockbuster success of Gd-DTPA (gadolinium diethylenetriamine penta-acetic acid) for enhancing cranial and spinal images acquired by MRI encourages a search for other winning agents.
“I am not purely in a theoretical field,“ said Kiessling, “clinical translation of research is very much a focus of what we do in Aachen.“
He heads three distinct work groups, one specialized in PET-MR detectors, one working in molecular ultrasound techniques, and the third a 'theranostic' group researching optimal strategies that fuse therapy and diagnostics.
The ultimate goal of this group are the magical, mythical remedies that one day will fix cellular dysfunctions as fast as they find them.
Kiessling's enduring belief in molecular diagnostics is founded in basic biology.
Understanding metabolic functions down to the level of tissue today is becoming more and more important in the diagnosis of disease and the evaluation of therapy response.
Meanwhile therapeutics are becoming more specific and are only effective for specific sub populations of patients that can be identified through highly targeted testing.
“All non-traumatic disease starts at the cellular level and with tissue,“ he said. “This is where we see the early signs of disease and with the right agent, we can image it.“
“This is what molecular diagnostics is all about,“ he said.
Price war unofficially declared for digital X-ray
The conversion to digital radiography (DR) is accelerating in Europe and system vendors are bracing for a price war as competition heats up.
Heading into the second half of the game the action is shifting down market as manufacturers take up positions to catch the sizable segment of laggards and hold outs.
At ECR, Siemens Healthcare (Erlangen, Germany), the lead vendor of X-ray in Europe, launched a new entry-level DR system that it openly promoted as “one-third below comparable predecessor products.“
It is the first time a manufacturer has positioned an X-ray product leading with a price point.
It was also the first time a major European manufacturer promoted its Asian connections in building the product.
The new Multix Select DR was developed by a team of German, Chinese and Spanish engineers, Siemens announced in its communication materials.
The head of global marketing for Siemens X-ray products, Georg Buchheim, MD, told BB&T the Multix system will be assembled in China and the projector tubes will be manufactured there.
On the exhibition floor, BB&T learned the flat panel detector will be produced in the U.S. by Varian Medical Systems (Salt Lake City), marking a significant break from Siemens' long-standing partnership in Trixel (Moirans, France), a joint venture with Philips Healthcare (Eindhoven, the Netherlands) and Thales (Paris).
To this point vendors have walked carefully around price is the competition to convert customer from film-based analog X-ray to DR.
“We say we give access to technology at an affordable cost,“ said Marc Mougel, General Manager of X-Ray for GE Healthcare (Chalfont, UK).
“When we launched the Healthymagination campaign two years ago, we did not say the lowest price, but affordable,“ he said, adding “it looks like Siemens is now following our lead.“
According to Buchheim at Siemens, “some manufacturers have been promoting affordability for a long time, but we are delivering on the promise.“
Eric Maurincomme, VP for Business Development and Strategy at Agfa Healthcare (Morstel, Belgium) said, “Our mission is not pricing but to deliver affordable solutions to the customer.“
“We have reached the tipping point for DR in Europe, and we want to accompany our customers in that transition,“ he said.
According to Maurincomme, recent economic pressures have revised the calculations of radiologists in deciding whether or not to switch to digital.
“The challenge for us as a film manufacturer is the price of the silver, which was trading at €13 ($18) a troy ounce last year and yesterday was at €35 ($49),“ he said.
“Film has a high content of silver and some customers who see the increase reflected in film prices are going to decide that now is the moment to get rid of the chemicals once and for all,“ he said.
Meanwhile, he said, the price of DR technology is going lower.
The lead for DR equipment sales in Germany for Fujifilm Imaging Systems (Düsseldorf, Germany) Joachim Verheggen said the price of flat panel detectors has fallen 30% from two years ago.
Though DR X-ray systems sell at a premium over conventional X-ray, Detectors are the most expensive component in a DR X-ray system.
Jean-Sébastien Argeles with Thales, the commercial arm of the Trixel joint venture, told BB&T the falling prices in detector panels has been closer to 20% but has accelerated in the past 12 months.
Thales is the leading supplier of detector panels in Europe, having sold 25,000 since the Trixel launch in 2007.
Both Fuji and Thales executives agreed the pressure on X-ray systems pricing is coming from Asia.
New this year at ECR was Comed Medical Systems (Gyeonnggi-do, South Korea) whose Manager of International Business, Ryan Cho, said his objective is less with radiologists than finding distributors.
Shenzhen Landwind Industry (Shenzhen, China) is a DR system manufacturer that has been a regular at ECR, though they are still seeking a major win in Europe and continue to build distribution agreements.
“We see a huge market in Europe and a tremendous opportunity where price plays an important role,“ said Jeff Wang, the manager for international sales.
“Siemens, Philips and GE dominate the market and have the strength to block new market entrants, so we definitely feel the pressure,“ he said.
The company is focused on Eastern Europe as a point of entry, “and elsewhere we are learning the market dynamic, learning how purchasing decisions are made and the features that customers want,“ he said.
“Our products have been designed and built according to the requirements of our domestic market so it takes a certain time for us to learn from doctors in Europe, and also to win their confidence in our products,“ he said.
The migration to digital began 10 years ago and the U.S. crossed over the digital divide in 2005, the first year that more digital than analog X-ray systems were sold.
Here in Europe the transition has been slower, and reflects the fragmented landscape of the market.
According to Massimo Rosa with Carestream Health (Herts, UK), the leading seller of film in Europe, the game is over in Scandinavia and Germany as those markets are almost fully running digital systems.
The UK is running over 80% DR today and will finish converting by 2012.
“Film remains big moving south into France, Spain and Italy where DR systems still only account for roughly 40% of exams,“ he said.
In Eastern Europe, outside of Poland and perhaps the Czech Republic, it is the exception for a customer to have converted to DR, he said.
“Carestream is the market leader for film in Europe, and we intend to keep this dominance until we sell the last square meter of film to the last customer in Europe,“ he said.
Elastography wins acceptance of BI-RADS panel
Leading ultrasound companies have been straining for years to make a case for elastography.
Hitachi Medical (Tokyo), Toshiba Medical Systems (Otawara, Japan) and more recently, Philips Healthcare have demonstrated the effectiveness of elastography for characterizing tissue stiffness.
The recent Medica trade show in Düsseldorf saw a dozen ultrasound systems from China and Korea promoting a tissue harmonics function as they move their low-end, low-priced systems up the scale with higher processing capabilities.
But cutting through this crowded field comes a large-scale clinical study for ShearWave from SuperSonic Imagine (Aix-en-Provence, France) that is creating a new model for quantifiable elastography and rapidly rolling up support from key opinion leaders.
Using a subset from its larger study of 1,800 patients from 16 American and European sites, the SuperSonic study presented at ECR showed that where a data point generated using ShearWave, the maximum elasticity value, was added to the BI-RAD scoring determined using from a B-mode assessment, the result was an 8% increase to specificity and a 5% increase to positive predictive value.
The now completed study arrives just in time to influence criteria proposed in the upcoming Fifth Edition of the BI-RADS lexicon, the Breast Imaging Reporting and Data System Atlas from the American College of Radiology (ACR; Reston, Virginia).
The reference scoring for lesions in 80% of radiology reports worldwide, BI-RADS classes breast lesions on a scale from zero to six, moving from an assuring finding of no concern for the woman to the confirmation of a malignancy.
Yet the inclusion in the new edition of elastography as a technique to qualify the scoring of a breast lesion, should have been Hitachi's crowning moment.
Hitachi invented Real-time Tissue Elastography in 2004, a year too late to be included in the Fourth BI-RADS that is currently in use.
Maintaining clinical leadership during the eight years leading up to the revision of BI-RADS, Hitachi progressively won over the ACR's BI-RADS ultrasound panel.
Yet it is the late-arriving ShearWave technique from SuperSonic that is turning heads on the BI-RADS ultrasound working group.
The second reading of results validating the recently released SuperSonic study was conducted by Wendie Berg, MD, an ACR fellow who is a member of the BI-RADS Ultrasound and Mammography Lexicons group.
Echos of support for ShearWave
Calling himself the token foreign member of the ACR committee, Professor Giorgio Rizzatto, MD, from the Azienda Ospedaliero Universitaria (Udine, Italy) presented an update on BI-RADS for radiologists at ECR, where he announced elastography would be included in this Bible of breast lesion scoring.
He outlined the three competing elastography techniques, each of which will be treated in the new BI-RADS lexicon.
Ultimately, he cautioned colleagues, elastography will only be a descriptor, complementary to a diagnosis that continues to depend upon the radiologist's visual assessment of tumor characteristics as outlines in the BI-RAD lexicon.
Having said that, Rizzatto went on to say the ShearWave technique “is the most important, the most exciting tool, and is the future of the technique.“
Speaking with BB&T after the session, Rizzatto acknowledged the clinical results reported by Hitachi using its compression technique for elastography and the results using the ShearWave technology “are very close, but ShearWave results are reproducible with quantification, and is easier to use,“ he said.
“In two to three years ShearWave will be the gold standard for breast imaging with ultrasound,“ he said.
Reproducible results is the Achilles heel for the compression technique, used by Hitachi and the crowd of imitators.
Both techniques measure a disruptive force that is sent through the echo signals sent by the ultrasound transducer as it is passes over the area of the breast where a suspicious mass has been seen in the B-mode.
The compression technique uses a disruption caused by a mechanically applied force.
Simply put, the ultrasound operator presses down on the breast tissue with the ultrasound transducer and then lets up on the pressure, creating a displacement in the signal that can be measured to determine the relative stiffness of the tissue.
SuperSonic uses a second sonic pulse from the transducer to create the disruption, thus the name ShearWave.
Because compression depends on a variable movement, the measure of the tissue density is dependent on the skill of the operator.
During a scientific session titled, “Elasto Practical Overview, Is It of Use,“ Ingrid Schreer, MD, professor of radiology at the University Hospital Schleswig-Holstein (Kiel, Germany) described the two techniques.
One of the authors of a landmark study reporting the influence of breast ultrasound on cancer detection for more than 100,000 procedures, Schreer is experienced in both techniques.
Acknowledging the free-hand compression technique for elastography is highly dependent on the operator's experience, she reported to colleagues studies showing remarkably consistent results in lesion characterization with a sensitivity upward of 89.7% and specificity at 83% and higher.
Her investigations of ShearWave is very encouraging, she said, citing the reproducibility of results, a capability for quantitative mapping of tissue characteristics, and what she termed, “a local assessment of stiffness with fine resolution.“
While she welcoming this development in elastography, she told BB&T the broader availability of ultrasound scanners using compression to test stiffness means the overwhelming majority of breast exams will be performed using this technique for some time to come.