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

这个小企业技术转移（STTR）一期项目的更广泛的影响/商业潜力将是为早期乳腺癌患者提供一种全面的治疗选择，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手术的约20万名乳腺癌患者中，有20%必须再次手术，因为最初的手术没有明确的边缘。此外，大多数接受乳房肿瘤切除术的乳腺癌患者还必须接受长达7周的昂贵（17,000美元以上）放射治疗。此外，由于需要辅助放射治疗，乳房肿瘤切除术并不是全球许多乳腺癌患者的选择。然而，术中使用射频消融（RFA）破坏肿瘤周围的薄边缘组织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，常用于肝癌和肾癌的治疗。然而，目前还没有为乳房肿瘤切除术后的乳房设计RFA装置。这种装置的开发将使世界各地的早期乳腺癌患者在几分钟内接受局部治疗，而费用只是放射治疗的一小部分。该项目旨在开发乳房肿瘤切除术后射频消融治疗技术。所提出的RFA装置被设计成这样，它将机械地适应手术腔均匀，以获得最佳治疗。然而，由于肿瘤和皮肤的位置，设备周围的均匀消融深度并不总是理想的。因此，该项目还提出了一种自动化系统，可以由外科医生预先编程来控制RFA设备产生的三维消融形状。该项目具有以下智力优势：(1)一个可以创建组织消融状态三维地图的系统（未消融、正在消融、消融）；(2)利用RFA装置创建三维烧蚀形状的系统。这些控制系统将通过动物组织的台式实验进行开发和验证。未来，这将使早期乳腺癌患者接受乳房肿瘤切除术后RFA的最佳定制治疗，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.