It's been a challenging time for ultrasound contrast advocates in the U.S. The technology's use in echocardiography continues under a cloud from the U.S. Food and Drug Administration's (FDA) black box warning last year, and the agency still has yet to provide clearance for use in radiology applications. But the International Contrast Ultrasound Society (ICUS) aims to help change all that.
Formally launched at last week's Advances in Contrast Ultrasound: Enhanced Atherosclerotic Imaging and Intervention conference in Chicago, ICUS is a global and multidisciplinary organization, according to co-presidents Dr. Steven Feinstein, director of echocardiography at Rush University Medical Center in Chicago, and Dr. Barry Goldberg, director of the Jefferson Ultrasound Research and Education Institute at Thomas Jefferson University Hospital in Philadelphia.
The ICUS aims to help meet a number of key challenges for the modality, including dealing with the ongoing black box warning from the FDA for use in echocardiography.
"The first step is to understand what needs to be changed for us to have an ongoing dialogue with the FDA and other organizations about safety," Feinstein said. "That I think is the strongest thing we can do."
While radiology and cardiology have not always seen eye-to-eye on imaging issues over the years, the FDA's June 24 Cardiovascular and Renal Drugs Advisory Committee meeting on the safety of ultrasound contrast helped bring the two groups together in the hope of advancing the technology, according to Goldberg.
"We found common ground," Goldberg said. "As physicians, we want to help the patient, and we know from personal research experiences and from our colleagues in many countries around the world, using contrast agents for cardiac and abdominal imaging provides information that makes better diagnoses, and I personally believe -- and people have talked about it in other countries -- saves lives. And we want that for this country as well."
The most important society objective right now is the promotion of safe and efficacious use of contrast-enhanced ultrasound (CEUS) in patients with diverse medical profiles and disease states, Feinstein said.
"We're all faced with addressing the safety and efficacy issues straight up front and ultimately," he said.
ICUS also aims to provide a global, interdisciplinary forum to foster education, research, and development of CEUS applications, as well as to facilitate open and dynamic communications among medical professionals and scientists in the fields of cardiology, radiology, gastrointestinal medicine, vascular medicine, internal medicine, hepatology, and other medical specialties and basic science disciplines.
"We wanted to be inclusive not only here in the [U.S.] but around the world, and that's why we have representatives truly from all over the world," Goldberg said. "That way we can all keep up on what's happening in the world and more rapidly disseminate information."
The society plans to publish a regular newsletter to keep members informed of ultrasound contrast developments. In addition, the society also would like to foster education of the public on the safe and efficacious use of CEUS in patients, and to create awareness in the medical community about the clinical benefits of CEUS, according to ICUS.
For an ICUS membership form and related information, click here. Membership is free. While vendor representatives are welcome to become members of the society, they will not be part of the society's leadership, Goldberg said.
"We want to work with vendors but we don't want to have any of them sitting on our board or influencing us," Goldberg said.
ICUS will have liaison relationships with vendors as well as other professional societies such as the American Institute of Ultrasound in Medicine (AIUM), the American Society of Echocardiography (ASE), and the World Federation for Ultrasound in Medicine and Biology (WFUMB).
"[ICUS] will take some pressure off the larger organizations as well, which have multiple agendas on their menu," Feinstein said. "We are very focused on the use of contrast for patient care. We look forward to a very good relationship with our established, much larger societies."
As the ICUS gets under way, Goldberg and Feinstein also noted some positive recent developments in ultrasound contrast. One company indicated at last week's meeting that it will be doing a phase III trial evaluating ultrasound contrast for characterizing liver masses, Goldberg said.
"They are moving rapidly to get this done, and we're quite excited about it," he said. "This shows that by getting together we have sort of restimulated the whole community, both physicians and industry. I think it's giving them the encouragement to go ahead."
In echocardiography, progress is being made in creating the FDA-requested registry for both contrast agents used in the U.S., as well as the additional trial necessary to remove the black box warning, Feinstein said.
By Erik L. Ridley
AuntMinnie.com staff writer
September 25, 2008
Related Reading
FDA updates ultrasound equipment guidance, September 18, 2008
Definity echo contrast agent lands on FDA drug safety list, September 8, 2008
FDA formally updates echo contrast black box warning, July 18, 2008
FDA ultrasound contrast safety meeting sparks discussion, hope for the future, July 10, 2008
More study of heart imaging agent risks urged, June 25, 2008
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