SBIR Phase I: Intraoperative detection and ablation of microscopic residual cancer in the tumor bed

This Small Business Innovation Research Phase I project will develop an intraoperative laser ablative device to simultaneously detect and treat residual cancerous cells in the tumor bed after bulk removal of tumors. Currently, the surgeon sends the resected tumor tissue to pathology to determine whether the surgical margins are clear (clean) of cancer cells. If the margins are not clean, the patient must return for a second surgery. We have developed a fluorescent molecular imaging agent and a wide-field-of-view imaging device to detect residual cancer cells with single cell resolution. The surface is illuminated by a laser and the imaging agent causes the cancer cells to fluoresce at a very specific wavelength. In this NSF-sponsored program, we propose to incorporate ablative technology to this imaging system so that the detected residual cancerous cells can be simultaneously detected and eliminated in real-time during the surgery. Specifically, we will incorporate ablation to our laser imaging system, register the pixel location of cancer targets, destroy the targets with the laser, and provide a feedback confirmation. The broader impacts/commercial potential of this project are 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. Our system will 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 our imaging system, would allow the surgeon to thoroughly eradicate cancer cells with minimal added work and no adverse effect on surrounding tissue. Our 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.