TAS::75 0849::TAS SBIR TOPIC 307 PHASE I NOVEL IMAGING AGENTS TO EXPAND THE CLINICAL TOOLKIT FOR CANCER DIAGNOSIS, STAGING, AND TREATMENT

Phase I - Topic 307 Lumicell's technology is an intraoperative imaging agent used in conjuction iwht our novel hand-held detector. Together they detect single residual cancer cells in the tumor bed, which guide the surgeon to complete removal of cancer. The aims of this project are to extend the characterization of the technology from sarcoma to breast cancer (mouse model) and to develop and test the accompanying next generation detection software. The software development proposed herein will require development of a novel algorithm based upon the characterization data which automates the calibration with no impact to the surgeon workflow. In the current practice, surgeons send the resected tumor to pathology to determine if surgical margins are clear of cancer cells. Pathology typically finds that 50%of breast cancer lumpectomies and 35% of sarcoma patients require second surgeries due to positive margins, 25% of the time, final pathology does not detect residual disease due to sampling errors fundamentally inherent in the process. Thus, most patients also require adjuvant therapy to prevent recurrence and metastasis from residual disease. This technology will have a significant impact by assuring clean margins from the initial surgery. The obvious resultsare a reduction in healthcare costs and improved patient care.