Dr. Barbara Smith on a Cutting-Edge Imaging Platform That Illuminates Residual Breast Cancer

By Dr. Barbara Smith, Rob Dillard - Last Updated: March 26, 2025

Recent clinical trial results demonstrated the potential of an investigational visualization system to identify residual breast cancer following removal of the primary specimen during initial lumpectomy. In the study, the Lumicell Direct Visualization System (DVS) identified cancer remaining after the standard-of-care lumpectomy procedure in approximately 8% of patients. In the majority of these patients, standard pathology assessment had deemed margins negative and would have left the tumor behind.

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The challenge with breast cancer surgery is that surgeons often don’t achieve what is considered to be a complete cancer resection during the initial lumpectomy. Today’s standard of care involves examining the margins of excised tissue to infer whether any residual cancer remains behind in the breast cavity. Until now, surgeons have had no way to look inside the patient to find and remove residual cancer during the initial lumpectomy. As a result, 20% to 40% of lumpectomies have positive margins only identified days after surgery, necessitating a second surgery to obtain clear margins. If approved, the Lumicell DVS would be the first and only system of its kind for breast cancer; the company recently submitted a New Drug Application and Premarket Approval Application for the imaging agent and system.

DocWire News spoke with Barbara Smith, MD, PhD, of Massachusetts General and principal investigator of this study, to learn more about the LumiSystem and how it enhances breast cancer detection.

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