Could Ultrasound-Beating Diagnostic Specificity in Breast Cancer Screening Remove Need for Biopsy?

The use of the Seno Imagio breast imaging system and its associated predictive model appear to have the potential to significantly improve the physicians’ ability to accurately rule out breast cancer compared to traditional ultrasound alone. So says a newly presented study.


According to the American Cancer Society’s estimates, 232,340 new cases of invasive breast cancer and an additional 64,640 cases of in situ breast cancer were diagnosed and approximately 39,620 women in the U.S. died from the disease during 2013. Only lung cancer accounts for more cancer deaths in women.

Seno Medical Instruments, Inc., is pioneering the development of what is termed opto-acoustic technology as a new tool to improve the process of diagnosing breast cancer. Seno’s Imagio breast imaging system fuses opto-acoustic technology with ultrasound to generate functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around suspicious breast masses while the ultrasound provides a traditional anatomic image.

Through the appearance or absence of the two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno believes that Imagio images will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents.

The aforementioned predictive model is based on key opto-acoustic features of breast masses obtained by Imagio during a 79 subject pilot study. Seno completed active enrollment of 2,100 subjects in the U.S.-based PIONEER study in September. The results of the study will serve as the basis for the company’s FDA PMA application.

Results of the parallel reader study, which was designed to prospectively test the predictive model, were presented at the 18th SIS World Congress on Breast Healthcare in mid October.

Using the Imagio system coupled with the predictive model, three independent radiologist were able to improve their ability to accurately classify a suspicious breast mass as benign by 28%, 36% and 38% achieving better specificity than with conventional gray scale ultrasound, respectively. Incremental improvements in specificity attributable to the predictive model (over subjective assignment) were 17%, 12%, and 13%.

Physician comments

“Diagnostic specificity, or the ability to accurately identify benign masses, remains disappointingly low for imaging methodologies optimized to identify all cancerous lesions with near 100% sensitivity,” said A. Thomas Stavros, MD, Medical Director, Seno Medical Instruments. “We believe that by training Imagio readers with this real-time predictive model, they may be able to accurately reclassify benign breast lesions to a lower BI-RADS score so the patient can confidently avoid a biopsy on benign masses. If confirmed by Seno’s prospective, multicenter PIONEER Pivotal Study of Imagio, the predictive model may improve the image reader’s ability to accurately characterize solid breast masses as cancerous or benign and to spare women with benign lesions from the biopsy process beyond the standard-of-care today.”

Company comments

“We are dedicated to improving the standard care for women after a suspicious mass is identified in one of their breasts. This new predictive model showed the increased potential of opto-acoustic images to help physicians confidently classify breast masses as benign, possibly eliminating the need for biopsies on certain breast masses,” said CEO Janet Campbell. “We are completing the follow-up of all subjects who participated in our U.S. pivotal study and will submit these additional promising data sets to the FDA as part of Seno’s PMA data package.”

Source: Seno Medical Instruments, Inc., PR Newswire

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