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

基本信息

批准号：
10439144
负责人：
Allison Payne
金额：
$ 53.54万
依托单位：
UNIVERSITY OF UTAH
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-02-01 至 2025-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10439144
关键词：
Ablation Acceleration Algorithms Alprostadil Applications Grants Breast Breast Cancer Patient Breast Cancer Treatment Breast Cancer therapy Breast Diseases Breast conservation Cicatrix Clinical Clinical Treatment Clinical Trials Collaborations Computer software Data Early treatment Ensure Environment Fatty acid glycerol esters Fiber Optics Focused Ultrasound Gadolinium Histology Histopathology Hybrids Image Immunohistochemistry Industrialization Industry Infection Institution Intervention 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 Protocols documentation Recovery Research Personnel Resected Resources Safety Scanning Scientist Site System Techniques Technology Temperature Thermometry Time Tissues Translating Translations Universities Utah Validation Work aqueous clinic ready clinical translation cost experience functional disability 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 system novel optical fiber parent grant pre-clinical preclinical evaluation prototype psychological distress real time monitoring safety assessment simulation tool treatment planning tumor ultrasound

项目摘要

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 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. We have developed a rapid, treatment planning package to predict ultrasound beam placement and assess potential beam aberration, a hybrid MR thermometry method to monitor temperature in both fat and aqueous based tissues and validated a novel MRI-registered whole mount histology technique that compares MRI metrics to histopathological analysis. This R37 2-year extension proposal will continue this work between experienced academic investigators at the University of Utah and industry investigators at Image Guided Therapy. This extension will finish and extend this important work, integrating each component into ThermoGuideTM, a clinic-ready focused ultrasound software control environment. Specifically, we will: 1) Use the rapid treatment planning technique to evaluate the necessity for phase aberration correction techniques in breast MRgFUS, 2) validate the accuracy and precision of our hybrid, breast-focused volumetric MR thermometry method, 3) apply our novel MRI-registered whole mount histology technique that compares MRI metrics to histopathological analysis to immunohistochemistry data and 4) evaluate the entire protocol in a feasibility treat-and-resect clinical trial targeting unifocal invasive breast cancer tumors. This R37 extension application will complete the validation and translation of the breast MRgFUS System in this proposal, providing 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入性的治疗发展了几十年微创保乳疗法的技术。我们的乳房特异性磁共振引导聚焦超声系统以高分辨率无创地将聚焦能量输送到身体深处图像引导。我们所取得的技术进步使 MRgFUS 成为一种几乎准备就绪的非侵入性方法局部乳腺疾病的消融治疗。我们开发了一个快速的治疗计划包预测超声波束位置并评估潜在的光束像差，这是一种混合 MR 测温方法监测脂肪和水基组织的温度，并验证了一种新型 MRI 记录的整体将 MRI 指标与组织病理学分析进行比较的安装组织学技术。此 R37 2 年延期该提案将继续犹他大学经验丰富的学术研究人员和图像引导治疗的行业调查员。这次扩展将完成并扩展这项重要的工作，将每个组件集成到 ThermoGuideTM 中，这是一款临床就绪的聚焦超声软件控制环境。具体来说，我们将： 1) 使用快速治疗计划技术来评估治疗的必要性乳腺 MRgFUS 中的相位像差校正技术，2) 验证我们的准确性和精确度混合型乳房聚焦体积 MR 测温方法，3) 应用我们新颖的 MRI 配准整体安装将 MRI 指标与组织病理学分析和免疫组织化学数据进行比较的组织学技术 4) 在针对单焦点侵入性乳腺的治疗和切除临床试验中评估整个方案的可行性癌症肿瘤。这个R37扩展应用程序将完成乳房的验证和翻译本提案中的 MRgFUS 系统为以下患者提供了令人兴奋的新型图像引导非侵入性治疗选择：乳腺癌患者。