Intraoperative lumpectomy cavity margin analysis with far-red fluorescence to reduce volume of tissue excised during breast cancer lumpectomy surgery.

e12605Background: Obtaining clear margins in breast cancer lumpectomy surgery is made difficult by complex tumor geometry and lack of rapid, accurate approaches for intraoperative margin assessment. 20-40% of patients have positive margins that require second surgeries. These increase volume excised, worsen cosmetic outcomes and add to patient discomfort and cost. In a prospective Phase II trial we assessed the ability of the LUM2.6 Imaging System to obtain clear margins while reducing volume of breast tissue excised. Methods: Women with invasive breast cancer and/or ductal carcinoma in situ (DCIS) received an IV injection of LUM015, a cathepsin-activatable fluorescent dye, 4±2 hours prior to surgery. A standard lumpectomy was performed and lumpectomy cavity walls were evaluated intraoperatively with the technology. Complete shaved cavity margins and remaining areas of high fluorescence were excised, analyzed with standard histopathology and compared to LUM Imaging System results. Volume of tissue excised...