Study Evaluates Portable MRI for Intraoperative Margin Assessment of Excised Breast Tumors
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ClearCut Medical announced the results of a study evaluating its portable MRI system, ClearCoast, that performs real-time intraoperative margin assessment of excised breast tumors during breast conserving surgery (BCS). Clear margins are critical in order to minimize the risk of recurrence and the need for retreatment.
The study, presented at the San Antonio Breast Cancer Symposium, aimed primarily to compare retreatment proportion within and between study groups with accordance to the SSO-ASTRO guideline. The secondary endpoint compared ClearCoast and the Standard of Care (SoC) diagnostic ability to detect positive margins intraoperatively, as well as the total excised breast tissue volume between study groups.
"ClearCoast is the most promising technique currently available for intraoperative margin assessment in breast conserving surgery of in situ and invasive breast cancer," said Prof Dr Marc Thill, director of the Department of Gynecology and Gynecological Oncology at the Agaplesion Markus Hospital in Frankfurt, Germany and PI of the study. "Following previous trials and after using the technique in our interventional post-marketing ClearCoast study, I am convinced that the technique is ready for clinical routine."
ClearCoast demonstrated a sensitivity of 81% and a specificity of 70%. It detected 92% of the DCIS compared to 18% in the control group. Moreover, the surgeon removed less breast tissue (69.9cm3 vs. 153.2 cm3) without increasing the duration of the procedure.
ClearCoast also showed a potential for an 80% reduction in re-excisions.
"These results emphasize its potential in reducing the burden of re-excision for patients and the Healthcare costs without trading off time for precision", said Hezi Himelfarb, CEO of ClearCut Medical. "The intuitive display of the system produces images that can be immediately interpreted by the surgeon, without the need for other specialists."
The system received CE Mark approval and is being sold in Europe by pfm medical gmbh.