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

STTR II 期：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

基本信息

批准号：
1738541
负责人：
Robert Rioux
金额：
$ 48.62万
依托单位：
Innoblative Designs
依托单位国家：
美国
项目类别：
Standard Grant
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-15 至 2020-02-29
项目状态：
已结题

来源：
https://www.nsf.gov/awardsearch/showAward?AWD_ID=1738541&HistoricalAwards=false
关键词：
STTR Phase II Automated system

项目摘要

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project will focus on the design of the first completely automated radio frequency ablation (RFA) system for breast tissue. Of the approximately 200,000 breast cancer patients in the US who elect lumpectomy annually, over 20% must undergo re-operation due to lack of clear margins. Furthermore, many breast cancer patients who are treated with lumpectomy require expensive adjuvant radiation therapy that can last up to 7 weeks causing time away from work and family. Fortunately, performing intraoperative RFA of the lumpectomy cavity has been shown to decrease the need for re-operations and radiation therapy by sterilizing tumor margins. However, no RFA devices are designed for post-lumpectomy breast cavities or breast tissue. The RFA system being developed in this project will automate post-lumpectomy RFA, accurately and precisely delivering energy based on local tissue properties and desired ablation depth in three dimensions thus customizing treatment for each patient. Eventual commercialization of this system could provide early stage breast cancer patients new treatment options that improve quality of life, reduce burdens of care, and costs while providing breast cancer recurrence control. The proposed project aims to develop a system (control unit and device) for optimal post-lumpectomy RFA. The proposed device is designed to mechanically fit the post-lumpectomy cavity for near-perfect tissue contact. The control unit includes advanced algorithms that utilize machine learning to create a three-dimensional ablation status map of each margin (ablation vs in-ablated) for controlling ablation. The combined system allows the surgeon to customize and monitor the three-dimensional ablation profile and automates therapy delivery to ensure accurate, precise ablation results. The objectives propose gathering device requirements, identifying critical tasks of an automated RFA procedure, and improving the system algorithm by collecting training data in cadaveric and prophylactic mastectomy specimens. The intellectual merits proposed are: (1) an automated ablation system implemented on an embedded microprocessor and co?]processor FPGA capable of ablation shape estimation and control; (2) a system that demonstrates clinical relevance through successful ablation in human tissue and surgeon usability.

该小型企业技术转让（STTR）第二阶段项目的更广泛影响/商业潜力将集中于设计首个用于乳腺组织的全自动射频消融（RFA）系统。在美国每年选择乳房肿瘤切除术的约20万名乳腺癌患者中，超过20%的患者由于缺乏清晰的边缘而必须接受再次手术。此外，许多接受乳房肿瘤切除术治疗的乳腺癌患者需要昂贵的辅助放射治疗，可能持续长达7周，导致工作和家庭时间减少。幸运的是，已证明对肿瘤切除术腔进行术中RFA可通过对肿瘤边缘进行消毒来减少再次手术和放射治疗的需要。然而，没有RFA器械设计用于乳房肿瘤切除术后的乳腺腔或乳腺组织。本项目正在开发的RFA系统将自动进行乳房肿瘤切除术后RFA，根据局部组织特性和所需的三维消融深度准确精确地输送能量，从而为每位患者定制治疗。该系统的最终商业化可以为早期乳腺癌患者提供新的治疗选择，提高生活质量，减少护理负担和成本，同时提供乳腺癌复发控制。拟议项目旨在开发一种系统（控制单元和器械），用于优化乳房肿瘤切除术后RFA。申报器械设计为与乳房肿瘤切除术后腔体机械匹配，以实现近乎完美的组织接触。控制单元包括先进的算法，该算法利用机器学习来创建每个边缘的三维消融状态图（消融与消融中），以控制消融。该组合系统允许外科医生自定义和监测三维消融轮廓，并自动进行治疗，以确保准确，精确的消融结果。目标是收集器械要求，识别自动RFA手术的关键任务，并通过收集尸体和预防性乳房切除术标本的培训数据来改进系统算法。提出的智能优点是：（1）自动消融系统上实现的嵌入式微处理器和co？能够进行消融形状估计和控制的处理器FPGA;（2）通过在人体组织中成功消融和外科医生可用性证明临床相关性的系统。