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

非侵入性、MR 引导的乳腺癌疗法的验证和转化

• 批准号: 10328883
• 负责人: Allison Payne
• 金额: $ 53.7万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-02-01 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10328883
• 关键词: Ablation; Algorithms; Alprostadil; Breast; Breast Cancer Patient; Breast Cancer Treatment; Breast Cancer therapy; Breast Diseases; Cicatrix; Clinic; Clinical; Clinical Treatment; Clinical Trials; Collaborations; Computer software; Data; Early treatment; Elements; Ensure; Environment; Fatty acid glycerol esters; Fiber Optics; Focused Ultrasound; Gadolinium; Gold; Histology; Histopathology; Image; Impairment; Industrialization; Industry; Infection; Institution; Intervention; Knowledge; Magnetic Resonance; Magnetic Resonance Imaging; Measurement; Methodology; Methods; Modeling; Monitor; Morbidity - disease rate; Operative Surgical Procedures; Patients; Phase; Phase I Clinical Trials; Planning Techniques; Procedures; Process; Recovery; Research Personnel; Resources; Safety; Scanning; Scientist; Site; System; Systems Integration; Techniques; Technology; Temperature; Thermometry; Time; Tissues; Translating; Translations; Universities; Utah; Validation; Work; aqueous; base; clinical care; clinical translation; cost; experience; high resolution imaging; image guided; image guided therapy; improved; in vivo; in vivo Model; industry partner; innovation; malignant breast neoplasm; minimally invasive; necrotic tissue; non-invasive imaging; non-invasive system; novel; pre-clinical; preclinical evaluation; prototype; psychological distress; real time monitoring; simulation; tool; treatment planning; tumor; ultrasound

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.

早期局部乳腺癌的治疗已经从高度侵袭性发展了几十年， 微创保乳治疗技术。我们的乳腺特异性磁共振引导 聚焦超声系统-“Muse”MRgFUS系统-非侵入性地将聚焦能量输送到深部 在高分辨率图像引导下进入体内我们取得的技术进步使MRgFUS 作为局部乳腺疾病的一种几乎现成的非侵入性消融治疗。其临床的最后步骤 翻译包括研究，以比较，优化和仔细验证治疗计划，实时监测， 和评估技术对最好的可用标准度量，其中包括侵入性温度 探针、水听器测量和组织病理学。这一建议对经验丰富的学术 犹他州大学的研究人员和影像引导治疗的行业研究人员。结合 学术合作伙伴的科学专业知识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一令人兴奋的技术的翻译。该提案将发展 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MR测温方法，和3）一种新的MRI注册的整体 将MRI指标与组织病理学分析进行比较的组织学技术。我们将整合每一个 这些经过验证的元素在一个临床准备，治疗软件控制环境，并将评估整个 在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中的过程。的 验证和翻译的缪斯系统在这个建议将提供一个令人兴奋的新的图像引导非， 乳腺癌患者的侵入性治疗选择。