Seno Medical Instruments on Monday released data from the pilot study portion of its Pioneer pivotal study examining its Imagio opto-acoustic tool designed to diagnose breast cancer.
The company said data from the trial showed Imagio system improved physicians’ ability to classify benign breast masses when compared to traditional ultrasounds methods. Data from the 100-patient pilot study was presented at the Radiological Society of North America’s annual meeting in Chicago earlier this month.
“Downgrading benign masses classified as BR 4b (moderate suspicion), 4a (low suspicion) and 3 without missing cancers is an unmet need that the Imagio OA breast imaging system can potentially help address. If these pilot findings are verified after the completion of the multicenter Pioneer Study, we will have confirmation that the Imagio OA breast imaging system could help women not only avoid biopsy procedures but also multiple short interval follow-up ultrasound exams over 2 years,” co-principal investigator Dr. Erin Neuschler of Northwestern University’s Feinberg School of Medicine said in a press release.
In the pilot study, independent specialists assessed 102 masses using the Imagio OA images, and were able to downgrade conventional diagnostic ultrasound findings of BR3 masses to BR2 masses in 33% of cases, BR4a masses to BR2 or 3 masses in 53% of cases and BR 4b masses to BR 3 or 2 masses in 33% of cases.
The initial pilot study is only part of a larger study slated to enroll over 2,000 subjects at multiple centers, Seno Medical said. The study aims to examine the ability of the Imagio system to downgrade Breast Imaging-Reporting and Data System scores, according to the company.
“Diagnostic specificity remains disappointingly low for diagnostic morphologic imaging modalities and reading algorithms that have been optimized to achieve very high sensitivity at the expense of low specificity – which, of course, results in many false positives and generates a high percentage of negative biopsies. These encouraging results indicate that Imagio can potentially offer physicians a tool to more accurately identify women who do not have breast cancer, and thus, who do not need to undergo invasive and expensive biopsy procedures and/or the stress of undergoing multiple follow-up exams over a 2 year period, depending upon whether the OA-based downgrade is to BI-RADS category 2 or 3. Reducing false positives and the number of negative biopsies, 2 of the main perceived and well-publicized ‘harms’ of breast cancer screening, may help defuse some of the criticisms being put forth by the anti-breast cancer screening movement. As breast radiologists, we can and we should do better in diminishing false positives and reducing negative biopsies. OA is a functional and morphologic diagnostic tool that has the potential to help us achieve better specificity without sacrificing sensitivity, diminish the percentage of negative biopsies generated by breast cancer screening, and to reduce the perceived ‘harms’ of breast cancer screening,” Seno medical director Dr. Thomas Stavros said in prepared remarks.
The Imagio system combines traditional ultrasound with light-based imaging, providing physicians with a closer look at “suspicious” breast masses without subjecting patients to radiation, injectable contrast agents or invasive biopsies.
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