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

这个小企业技术转让（STTR）第一阶段项目的更广泛的影响/商业潜力将为早期乳腺癌患者提供全面的治疗选择，在患者的第一次手术中完全消除所有癌症。目前，在美国每年接受乳房肿瘤切除术治疗的约200，000名乳腺癌患者中，有20%必须再次手术，因为初次手术缺乏明确的边缘。此外，大多数接受肿块切除术治疗的乳腺癌患者还必须接受昂贵的（17，000美元以上）放射治疗，最长可持续7周。此外，由于需要辅助放射治疗，乳房肿瘤切除术不是全球许多乳腺癌患者的选择。然而，术中用射频消融（RFA）破坏肿瘤周围组织的薄边缘已被证明可以减少再次手术和放射治疗的需要。RFA是一种热消融疗法，常用于肝癌和肾癌治疗。然而，没有针对乳房肿瘤切除术后的乳腺腔设计RFA器械。这种设备的开发将使全世界的早期乳腺癌患者能够在几分钟内接受局部治疗，而放射治疗的成本仅为放射治疗的一小部分。拟议项目旨在开发乳房肿瘤切除术后射频消融治疗技术。申报的RFA器械设计为能够均匀地与手术腔机械匹配，以实现最佳治疗。然而，由于肿瘤和皮肤的位置，并不总是期望设备周围的均匀消融深度。因此，该项目还提出了一种自动化系统，可由外科医生预编程，以控制RFA器械产生的三维消融形状。申报项目具有以下智力优势：（1）可创建组织消融状态三维标测图（未消融vs.消融vs.消融）的系统;（2）可使用申报RFA器械创建三维消融形状的系统。这些控制系统将通过动物组织的实验室实验进行开发和验证。在未来，这将使早期乳腺癌患者能够接受最佳的定制治疗，即乳房肿瘤切除术后RFA，以降低再次手术和未来癌症复发的风险。

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.