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

Period of Performance: 07/04/2016 - 06/30/2017


Phase 2 SBIR

Recipient Firm

Lumicell Diagnostics, Inc.
Wellesley, MA 02481
Principal Investigator


Project Summary/AbstractCurrent pre-operative and intraoperative margin assessment techniques fail to adequately guide breast cancersurgeons to remove all cancer during breast conserving surgeries. As a result, more than 30% of lumpectomypatients have unrecognized tumor left in the tumor bed during the initial surgery. This residual tumor is onlydiscovered 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 carecosts along with patient anxiety and discomfort. To address this unmet need, Lumicell has developed anintraoperative imaging system consisting of a molecular imaging agent (LUM015) that emits fluorescence afteractivation by cancer associated enzymes, a compact hand-held imaging head (LUM 2.6 Device) that capturesthe fluorescence emission of the agent and software that detects and displays invasive carcinomas (80% of thebreast cancer cases) in real-time to guide the surgeon. Our collaborators at the Massachusetts GeneralHospital are conducting a feasibility study in breast cancer patients under an FDA-approved IDE. The first partof the feasibility study has been completed with no adverse events observed in 15 patients. Initial resultsfrom the feasibility study show no false negatives (100% sensitivity) with ~10% false positives. During thisstudy, 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 ofour PMA application to measure the efficacy of the LUM Imaging System. The primary endpoint of the study isthe reduction in positives margin rates for surgeries in which the LUM Imaging System is used versus standardof care (SOC) treatment for breast cancer patients undergoing breast conserving lumpectomies. Thesecondary endpoint is a reduction in the rate of second surgeries due to positive margins when the LUMImaging System is used. The device arm will consists of 300 patients, while the control (SOC) arm will consistsof 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 ImagingSystem. Additional therapeutic cavity shaves will be removed from regions that Lumicell's detection algorithmdetermines to contain cancer.