Validation and translation of a non-invasive, MR-guided breast cancer therapy

早期局部乳腺癌的治疗已经从高度侵袭性的乳腺癌发展到几十年。 微创、保乳治疗的技术。我们的乳房特异性磁共振引导 聚焦超声系统-“缪斯”MRgFUS系统-非侵入性地将聚焦能量传递到深度 在高分辨率图像引导下进入体内。我们已经取得的技术进步，波斯MRgFUS 作为一种近乎现成的非侵入性消融治疗局部乳腺疾病。其临床应用的最后一步 翻译包括比较、优化和仔细验证治疗计划、实时监测的研究 以及针对最佳可用标准指标的评估技术，其中包括入侵温度 探头、水听器测量和组织病理学。这项建议是对有经验的学者提出的 犹他大学的研究人员和图像引导疗法的行业调查人员。结合了 学术合作伙伴的科学专长和技术知识与系统集成和监管 行业合作伙伴的专业知识将促进这项令人兴奋的技术的翻译。这项提议将得到发展。 并验证将MUSE系统转化为临床护理所需的其余要素，包括：1) 基于快速超声束建模方法的精确MRgFUS治疗计划，2)a 全面的乳房聚焦体积磁共振测温方法，以及3)一种新的MRI注册整体 安装组织学技术，将MRI指标与组织病理学分析进行比较。我们将整合每一个 这些经过验证的元素将在临床就绪的治疗软件控制环境中使用，并将评估整个 针对单灶性浸润性乳腺癌肿瘤的I期治疗和切除临床试验的过程。这个 本提案中MUSE系统的验证和翻译将提供一种令人兴奋的新的图像制导的非 乳腺癌患者的侵入性治疗选择。

The treatment of early stage, localized breast cancer has evolved over several decades from highly invasive techniques to minimally invasive, breast-conserving therapies. Our breast-specific magnetic resonance-guided focused ultrasound system – the “Muse” MRgFUS System – non-invasively delivers focused energy deep inside the body under high-resolution image guidance. The technical advances we have made poise MRgFUS as a nearly ready non-invasive ablation treatment for localized breast disease. The final steps for its clinical translation include studies to compare, optimize and carefully validate treatment planning, real-time monitoring and assessment techniques against the best available standard metrics, which include invasive temperature probes, hydrophone measurements and histopathology. This proposal pairs experienced academic investigators at the University of Utah with industry investigators at Image Guided Therapy. Combining the academic partner's scientific expertise and technological knowledge with the system integration and regulatory expertise of the industry partner will facilitate translation of this exciting technology. This proposal will develop and validate the remaining elements necessary to translate the Muse System into clinical care including: 1) accurate MRgFUS treatment planning based on a rapid ultrasound beam modeling method, 2) a comprehensive breast-focused volumetric MR thermometry method, and 3) a novel MRI-registered whole mount histology technique that compares MRI metrics to histopathological analysis. We will integrate each of these validated elements in a clinic-ready, treatment software control environment and will evaluate the entire process in a Phase I treat-and-resect clinical trial targeting unifocal invasive breast cancer tumors. The validation and translation of the Muse System in this proposal will provide an exciting new image-guided non- invasive treatment option for breast cancer patients.