{"id":5150,"date":"2017-11-27T20:34:31","date_gmt":"2017-11-27T20:34:31","guid":{"rendered":"https:\/\/senomedical.com\/?p=5150"},"modified":"2025-06-16T20:35:05","modified_gmt":"2025-06-16T20:35:05","slug":"seno-medical-instruments-imagio-opto-acoustic-breast-imaging-system-demonstrates-ability-to-downgrade-risk-classification-of-benign-breast-masses-in-a-prospective-european-clinical-t","status":"publish","type":"post","link":"https:\/\/senomedical.com\/index.php\/2017\/11\/27\/seno-medical-instruments-imagio-opto-acoustic-breast-imaging-system-demonstrates-ability-to-downgrade-risk-classification-of-benign-breast-masses-in-a-prospective-european-clinical-t\/","title":{"rendered":"Seno Medical Instruments\u2019 Imagio\u2122 Opto-Acoustic Breast Imaging System Demonstrates Ability to Downgrade Risk Classification of Benign Breast Masses in a Prospective European Clinical Trial"},"content":{"rendered":"

CHICAGO,\u00a0November 28, 2017 \u2013 Seno Medical Instruments, Inc. (Seno Medical), the leader in new technology for breast cancer diagnosis using optoacoustic (OA\/US) imaging to differentiate benign from malignant masses, today announced clinical data demonstrating that its Imagio\u2122\u00a0<\/sup>breast imaging system effectively downgraded the risk classification of benign breast masses and upgraded the risk classification of malignant masses compared with ultrasound (US) alone. The data are being presented today at 3:20 p.m. CDT during an oral presentation by a principal study investigator at the Radiology Society of North America 103rd<\/sup>\u00a0Annual Meeting, taking place November 26 \u2013 December 1 in Chicago.<\/p>\n

The prospective, controlled, multi-center study was conducted at five centers in the Netherlands between March 2015 and February 2016 and enrolled 217 patients at least 18 years of age with at least one breast mass totaling 223 breast masses classified as BI-RADS (Breast Imaging and Reporting Data System) category 4A or 4B and with a corresponding probability of malignancy (POM) ranging from >2% to 50% based on prior US assessment. The likelihood that a breast mass is malignant increases with increasing BI-RADS category number. All subjects underwent an OA\/US evaluation after conventional US and prior to biopsy. The OA\/US data were used to estimate the POM on a scale from 0% to 100% and, when appropriate, the BI-RADS classification determined by conventional US was adjusted. Biopsies were performed within 30 days of enrollment and after the OA\/US procedure had been performed and interpreted. The OA\/US results were compared with biopsy results as the reference standard. Patients were asked to complete a satisfaction survey after undergoing OA\/US evaluation<\/p>\n

\u201cThe negative consequences of biopsies of benign breast masses include pain, anxiety, fear, direct expenses and indirect expenses related to work missed and managing complications,\u201d said study investigator Gisela L.G. Menezes, M.D., Ph.D. and postdoc at the University Medical Center Utrecht, the Netherlands. \u201cUsing OA\/US, benign masses originally classified as suspicious may be downgraded to probably benign or benign, potentially decreasing the number of biopsies of benign lesions.\u201d<\/p>\n

Key findings from the study include:<\/p>\n