Seno Medical's Imagio Opto-Acoustic Breast Imaging System Proves Strong Predictor of Malignancy
May 16, 2017 ? Seno Medical Instruments Inc. recently announced that is Imagio opto-acoustic (OA/US) breast imaging system results correlate with the histopathological findings of benign and malignant breast masses. These data were highlighted during an oral presentation at the American Roentgen Ray Society (ARRA) Annual Meeting, May 1-5 in New Orleans.
The basis for this presentation is the institutional review board (IRB)-approved Phase III pilot study, which was designed to determine the histopathologic basis of OA/US breast imaging and investigate its ability to differentiate benign and malignant masses. A total of 92 patients with 94 solid or complex cystic and solid breast masses assessed as Breast Imaging-Reporting and Data System (BI-RADS) 3, 4 or 5 on conventional diagnostic ultrasound (CDU) were imaged with OA/US. For each mass, five pre-determined OA features ? three internal features and two external features ? were evaluated. The three internal features (internal vessels, blush and hemoglobin) and two external features (boundary zone vessels and peripheral zone vessels) were scored and correlated with benign and malignant histopathology.
Mean OA scores were higher for malignant masses compared to benign masses for all individual internal and external features, as well as for combined internal and external OA features. Statistical analysis showed that these differences were highly statistically significant. External features were more predictive of malignancy than internal features, with greater differences in their means and 99 percent confidence intervals between benign and malignant masses.
"These data reinforce previous findings suggesting that opto-acoustic diagnostic imaging may improve our ability to differentiate between benign and malignant breast masses. This could help us decrease the number of unnecessary breast biopsies performed for benign findings, reducing patient anxiety, discomfort and healthcare cost," said Reni Butler, M.D., principal study investigator and assistant professor of radiology and biomedical imaging at Yale University School of Medicine. "Unlike previously investigated functional modalities, opto-acoustic imaging provides real-time anatomic and functional information without ionizing radiation or the need for IV contrast injection, making it a potentially safer and more convenient option for patients."
The Imagio OA/US breast imaging system was designed and is being studied to identify two functional hallmarks of cancer: the presence of abnormal blood vessels (tumor angiogenesis) and the relative reduction in oxygen content of blood that occurs in cancer compared to benign masses and normal tissues. The technology is the subject of a U.S. PMA filing with the U.S. Food and Drug Administration (FDA).