A prospective, multi-center pivotal study of the LUM Imaging System for real-time, in vivo margin assessment in breast conserving surgery

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Project Summary/Abstract Current pre-operative and intraoperative margin assessment techniques fail to adequately guide breast cancer surgeons to remove all cancer during breast conserving surgeries. As a result, more than 30% of lumpectomy patients have unrecognized tumor left in the tumor bed during the initial surgery. This residual tumor is only discovered when the pathologist evaluates the resection margins one week later and finds a positive margin. The majority of patients with positive margins (~87%) require a second surgery, which increases health care costs along with patient anxiety and discomfort. To address this unmet need, Lumicell has developed an intraoperative imaging system consisting of a molecular imaging agent (LUM015) that emits fluorescence after activation by cancer associated enzymes, a compact hand-held imaging head (LUM 2.6 Device) that captures the fluorescence emission of the agent and software that detects and displays invasive carcinomas (80% of the breast cancer cases) in real-time to guide the surgeon. Our collaborators at the Massachusetts General Hospital are conducting a feasibility study in breast cancer patients under an FDA-approved IDE. The first part of the feasibility study has been completed with no adverse events observed in 15 patients. Initial results from the feasibility study show no false negatives (100% sensitivity) with ~10% false positives. During this study, Lumicell developed an approach for detecting the much smaller foci of ductal carcinoma in situ (DCIS; 20% of breast cancer cases). As the first aim of this proposal, we will develop and implement software for real- time detection of DCIS. Our next proposed aim is a two arm, multi-institution pivotal clinical trial in support of our PMA application to measure the efficacy of the LUM Imaging System. The primary endpoint of the study is the reduction in positives margin rates for surgeries in which the LUM Imaging System is used versus standard of care (SOC) treatment for breast cancer patients undergoing breast conserving lumpectomies. The secondary endpoint is a reduction in the rate of second surgeries due to positive margins when the LUM Imaging System is used. The device arm will consists of 300 patients, while the control (SOC) arm will consists of 100 patients. In the SOC arm, patients will undergo a routine lumpectomy procedure. In the device arm, patients will undergo SOC treatment followed by imaging of the lumpectomy cavity with the LUM Imaging System. Additional therapeutic cavity shaves will be removed from regions that Lumicell's detection algorithm determines to contain cancer.