The Canadian F.I.G.H.T. (Fluorescence Image-Guided Help in Treating) Breast Cancer Surgical Trial

Breast cancer, the most prevalent cancer in women, is treated by breast conservation surgery (BCS), where tumor is removed while preserving the maximum amount of healthy tissue. Under standard white light visualization, tumor borders are difficult for surgeons to visualize. Despite current best practice to guide optimum tumor resection, ~23% of Canadian women require a second operation to remove remaining cancerous tissue that wasn't detected during the initial surgery. Thus, there is an urgent clinical need for a new imaging tool that improves tumor visualization and guides the surgeon towards complete tumor removal - during the first surgery. To address this need, we developed a new Health Canada-approved handheld fluorescence imaging device (called PRODIGI) which we have clinically evaluated in combination with a safe clinically-approved tumor localizing imaging agent called 5-aminolevulinic acid (5-ALA) to detect breast cancers during surgery, based on the tumor's red fluorescence signal which is produced by ALA-induced protoporphyrin IX (PpIX), a natural molecular in the body. Based on encouraging initial results of our current feasibility trial, we now propose a prospective multicenter randomized control trial (RCT) over 5 years conducted by a multidisciplinary team across breast cancer centers at 6 Canadian health institutions in 4 provinces (ON, AB, SK, NS). The primary goals of this RCT will be to definitely determine the effectiveness of this new imaging approach in reducing re-excision rates and disease recurrence, while identifying potential impact on the quality of life for breast cancer patients and health economics, compared with the standard of care. If successful, we expect to eliminate at least 3000 second surgeries in Canada over 3 years, reduce surgical wait times, be deployed rapidly into surgical practice, especially in resource-limited areas, and reduce variability in BCS outcomes.