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.

早期阶段的治疗，局部乳腺癌已从高度侵入性的几十年中发展 微创乳房疗法的技术。我们的乳房特异性磁共振引导 集中的超声系统 - “缪斯” MRGFUS系统 - 非侵入性提供集中的能源深度 在高分辨率图像指导下体内内部。我们使MRGFUS镇定的技术进步 作为局部乳腺疾病的几乎现成的非侵入性消融治疗。临床的最后一步 翻译包括研究，优化和仔细验证治疗计划，实时监控 和针对最佳可用标准指标的评估技术，其中包括侵入性温度 探针，水文测量和组织病理学。该建议对经验丰富 犹他大学的研究人员与图像指导疗法的行业研究人员。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种令人兴奋的技术的翻译。该建议将发展 并验证将缪斯系统转化为临床护理所需的其余要素，包括：1） 基于快速超声梁建模方法的准确MRGFUS治疗计划，2）A 全面的母乳化体积MR温度法和3）新型MRI注册的整体 将MRI指标与组织病理学分析进行比较的安装组织学技术。我们将整合每个 这些已验证的元素在诊所就绪，治疗软件控制环境中，将评估整个 在I期治疗靶向统一侵入性乳腺癌肿瘤的临床试验中的过程。 本提案中缪斯系统的验证和翻译将提供令人兴奋的新图像引导的非 - 乳腺癌患者的侵入性治疗选择。