March 5, 2012 — Results of the largest clinical breast study sponsored by an ultrasound manufacturer have recently been published in the peer-reviewed Radiology and European Radiology medical journals. The multinational, multicenter “Breast Elastography 1 (BE1)” study assessed the clinical benefits of ShearWave Elastography (SWE) in the ultrasonic diagnosis of breast lesions.
The study had two objectives: The first was to demonstrate that images obtained using SWE were reproducible. The second was to compare ultrasound alone versus the combination of ultrasound and SWE for breast lesion characterization. The goal of the latter was to improve lesion classification in categories BI-RADS 3 and BI-RADS 4, where most treatment dilemmas occur, in order to better direct patients toward clinical short-term follow-up or biopsy.
The clinical study was launched in April 2008 with 17 American and European sites including: Hammersmith Hospital, the Imperial College of Medicine in London, the Curie Institute of Paris, the DKD Wiesbaden and the academic hospitals in Greifswald and Kiel, Schleswig-Holstein (Germany), Yale Medical Center, and Northwestern Memorial Hospital in Chicago. The study was conducted under David Cosgrove, professor at Imperial College of Medicine, and more than 1,800 breast lesions were assessed.
To determine reproducibility, each clinical investigator was asked to perform and compare features on three separate SWE image acquisitions of the same lesion. Results showed the technology was reproducible both qualitatively and quantitatively.
“The outcome of this study goes well beyond our expectations. The study protocol, as it was designed, did not introduce any a priori on the role of SWE as a complement to B-Mode. These published findings are providing the groundwork for a major clinical breakthrough in breast ultrasound. The results will certainly have an important impact on patient management in an area where the need for improvement in screening, diagnosis and therapy has been a driver for the entire medical community,” said Claude Cohen-Bacrie, executive vice president of SuperSonic Imagine and senior author of the two publications.
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