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

这个小型企业创新研究(SBIR)第二阶段项目旨在开发一种手持系统，癌症外科医生使用该系统来检测和消除肿瘤大体切除后肿瘤床上的微小残余癌症。集成的激光消融系统可以在手术过程中立即移除成像系统识别的癌细胞，消除了重复手术的需要。肿瘤的有效切除通常是困难的，因为需要保留肿瘤附近的基本组织(血管、神经、脑)，并且在手动切除时缺乏肿瘤床的视觉分辨率。在第二阶段开发的集成激光消融系统将通过快速和准确地消除肿瘤床上残留的癌细胞来增强外科技术。第二阶段的目标是提供一种可用于临床试验的系统，其中包括：提高消融速度，发展更大的视野，并在动物实验中展示疗效。该项目完成后，Lumicell将在人体临床试验中验证新系统的性能。该项目的更广泛影响/商业潜力源于患者护理的改善和医疗成本的降低。目前，大约50%的乳腺癌患者和35%的肉瘤患者需要进行第二次肿瘤去肿块手术，因为第一次手术后几天的最终病理报告表明，患者体内仍有残留的癌细胞。此外，25%的最终病理报告没有检测到残留的癌细胞，这是由于抽样过程中基本固有的错误。因此，大多数患者需要随后的药物治疗，包括额外的放疗或化疗，以防止癌症复发和因残留癌细胞而产生的转移。该系统旨在单细胞水平上实时发现并摧毁残留的癌细胞。邻近关键神经或脑组织的肿瘤尤其困难，由拟议的成像系统引导的激光治疗将使外科医生能够以最少的额外工作彻底根除癌细胞，并且对周围组织没有不良影响。Lumicell的新型单细胞成像设备与聚焦激光消融治疗相结合，将对防止二次手术和随后的药物治疗产生重大影响，从而显著节省医疗成本并改善患者护理。

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.