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

STTR 第一阶段：用于在肿块切除术后边缘消融乳腺癌治疗中创建定制三维射频消融病灶几何形状的自动化系统

• 批准号: 1622842
• 负责人: Robert Rioux
• 金额: $ 22.5万
• 依托单位: Innoblative Designs
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1622842&HistoricalAwards=false
• 关键词: STTR; Phase; Automated; system; creating

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.

该小企业技术转让 (STTR) 第一阶段项目的更广泛影响/商业潜力将是为早期乳腺癌患者提供全面的治疗选择，在患者第一次手术期间完全消除所有癌症。目前，美国每年接受乳房肿瘤切除手术的乳腺癌患者约 200,000 名，其中 20% 必须进行再次手术，因为初次手术缺乏清晰的切缘。此外，大多数接受肿瘤切除术治疗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，肿瘤切除术对于全球许多乳腺癌患者来说并不是一种选择。然而，术中通过射频消融 (RFA) 破坏肿瘤周围的薄层组织已被证明可以减少再次手术和放射治疗的需要。 RFA 是一种常用于肝癌和肾癌治疗的热消融疗法。然而，目前尚未为肿块切除术后的乳腔设计 RFA 设备。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，而费用仅为放射治疗的一小部分。拟议的项目旨在开发肿块切除术后射频消融治疗的技术。所提出的 RFA 设备的设计使其能够均匀地机械贴合手术腔，以实现最佳治疗。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，可由外科医生预先编程，以控制 RFA 设备产生的三维消融形状。该项目具有以下智力优点：（1）一个可以创建组织消融状态三维图（未消融、正在进行消融、已消融）的系统； (2) 一个可以使用所提出的 RFA 设备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台式实验进行开发和验证。未来，这将使早期乳腺癌患者能够通过肿瘤切除术后 RFA 接受最佳的定制治疗，以降低再次手术和未来癌症复发的风险。