SBIR Phase II: Intraoperative Detection and Ablation of Microscopic Residual Cancer in the Tumor Bed

This Small Business Innovation Research (SBIR) Phase II project is aimed at developing a handheld system that a cancer surgeon uses to detect and eliminate microscopic residual cancer in the tumor bed after gross resection of the tumor. An integrated laser ablation system instantly removes the cancer cells identified by the imaging system during surgery, eliminating the need for repeat surgery. Effective resection of cancer is often difficult because of the need to spare essential tissue (blood vessels, nerves, brain) adjacent to the tumor and the lack of visual resolution of the tumor bed during manual resection. The integrated laser ablation system developed in Phase II will enhance the surgical technique by quickly and precisely eliminating residual cancer cells in the tumor bed. The objective of Phase II is to deliver a system ready for clinical trials, which includes: increasing the ablation speed, developing a larger field of view, and demonstrating efficacy in animal studies. After completion of this program, Lumicell will validate the performance of the novel system in human clinical trials. The broader impact/commercial potential of this project stems from improvements in patient care and reduction of healthcare costs. Currently, around 50% of breast cancer patients and 35% of sarcoma patients require second tumor de-bulking surgeries because a final pathology report returns days after the initial surgery indicating that residual cancerous cells have been left within the patient. Furthermore, 25% of the final pathology reports do not detect residual cancer cells due to sampling errors fundamentally inherent in the process. Thus, most patients require subsequent medical therapy including additional radiation or chemotherapy treatment to prevent cancer recurrence and metastasis stemming from residual cancer cells. The system is designed to find and destroy residual cancer cells in real-time at a single cell level. Tumors adjacent to critical nerve or brain tissue are particularly difficult and a laser therapy guided by the proposed imaging system would allow the surgeon to thoroughly eradicate cancer cells with minimal added work and no adverse effect on surrounding tissue. Lumicell's novel single cell imaging device combined with focused laser ablative therapy will have a significant impact on preventing second surgeries and subsequent medical therapy resulting in significant healthcare cost savings and improved patient care.