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

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 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 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 LUM that emits fluorescence after activation by cancer associated enzymes a compact hand held imaging head LUM Device that captures the fluorescence emission of the agent and software that detects and displays invasive carcinomas 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 patients Initial results from the feasibility study show no false negatives sensitivity with false positives During this study Lumicell developed an approach for detecting the much smaller foci of ductal carcinoma in situ DCIS 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 patients while the control SOC arm will consists of 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 Lumicellandapos s detection algorithm determines to contain cancer Project Narrative The proposed project aims to address the unmet clinical need for intraoperative assessment and removal of residual cancer cells in the lumpectomy cavity after gross tumor resection in breast cancer patients A novel imaging method for fast and thorough imaging of the tumor bed in real time will be tested in a pivotal clinical study to measure efficacy in reducing positive margin rates and eliminating the need for repeat surgeries Successful completion of this project will enable the FDA approval required to put this technology in the hands of breast cancer surgeons improving care for breast cancer patients