Feasibility Study of Intraoperative Imaging in Breast Cancer

The LUM Imaging System consists of the cancer imaging agent LUM015 and a hand-held fluorescence-based imager that collects the emission of activated LUM015 in and around tumor. The LUM Imaging System is designed to detect microscopic residual cancer cells in real-time within the tumor bed. In this study, we will evaluate the performance of the LUM Imaging System in detecting residual cancer and guiding its removal during lumpectomies. In Phase A, all patients will receive standard of care surgery followed by intraoperative imaging of the tumor bed and resected tissue with the LUM 2.6 Imaging Device. In Phase A, no clinical decisions are made based on the imaging results. Standard of care margin assessment will be performed and compared against the imaging results with the LUM Imaging System. Subjects in Phase B will receive standard of care surgery followed by intraoperative imaging of the tumor bed with the LUM Imaging System. In Phase B, the surgeon will remove an additional shaved margin specimen if indicated by the LUM Imaging System. Final margin assessment will be performed on the very last shaved margin specimen removed. All participating subjects will be observed to collect safety data from the time of injection of LUM015 to the time the clinical team decides no additional surgery is needed.