STTR Phase I: Automated system for creating custom three-dimensional radiofrequency ablation lesion geometries in post-lumpectomy margin ablation breast cancer treatment

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project will be to provide early stage breast cancer patients with a comprehensive treatment option that completely eliminates all cancer during a patient's first surgery. Currently, >20% of the ~200,000 breast cancer patients who are treated with lumpectomy surgery annually in the US must have a re-operation because of a lack of clear margins in the initial surgery. Furthermore, most breast cancer patients who are treated with lumpectomy must also undergo expensive ($17,000+) radiation therapy that can last up to 7 weeks. Furthermore, due to the need for adjuvant radiation therapy, lumpectomy is not an option for many breast cancer patients globally. However, intraoperatively destroying a thin rim of tissue around the tumor with radiofrequency ablation (RFA) has been shown to decrease the need for re-operations and radiation therapy. RFA is a thermal ablation therapy used commonly in liver and kidney cancer treatment. However, no RFA devices have been designed for the post-lumpectomy breast cavity. Development of such a device will allow for early stage breast cancer patients worldwide to receive local therapy in minutes for a fraction of the cost of radiation. The proposed project aims to develop technologies for post-lumpectomy radiofrequency ablation therapy. The proposed RFA device is designed such that it will mechanically fit the surgical cavity uniformly for optimal treatment. However, a uniform ablation depth around the device will not always be desired due to the location of the tumor and skin. This project, therefore, also proposes an automated system that can be pre-programmed by a surgeon to control the three-dimensional ablation shape produced by the RFA device. The following intellectual merits are in the proposed project: (1) a system that can create three-dimensional maps of ablation status of tissue (unablated vs. undergoing ablation vs. ablated); (2) a system that can create three-dimensional ablation shapes using the proposed RFA device. These control systems will be developed and validated with benchtop experiments in animal tissues. In the future, this will allow early-stage breast cancer patients to receive optimal customized treatment with post-lumpectomy RFA to reduce the risk of re-operation and future cancer recurrence.