Non-Invasive MRI-Guided HIFU for Breast Cancer Therapy

描述（由申请人提供）：乳腺癌仍然是一种重要的疾病，对大量妇女产生不利影响。被诊断患有乳腺癌的妇女人数继续上升。虽然大多数患者在疾病中存活，但最大限度地减少治疗导致的任何残疾或毁容对患者未来的生活质量非常重要。尽管有更灵敏的MRI方法来检测乳腺病变和新的微创保守治疗形式，但在成像和治疗方面仍有很大的改进空间。MRI引导的高强度聚焦超声（MRgHIFU）有可能为乳腺局部病变提供完全无创的治疗。该提案解决了使MRgHIFU无法实现其非侵入性治疗局部乳腺癌的潜力的剩余限制。该项目建立在由犹他州高级成像研究中心、工程学院和医学院的科学家领导的学术/工业合作伙伴关系中开发的创新的乳腺特异性MRgHIFU系统的基础上，将验证该系统用于快速、有效和安全的非侵入性MRgHIFU治疗局部乳腺病变。该项目包括四个具体目标：1）开发针对患者的超声波束像差校正方法，以改善异质性乳腺中的超声焦点定位; 2）开发异质性乳腺脂肪和水组织温度测量的有效方法，以适当监测MRgHIFU治疗程序，从而确保完全的肿瘤消融并避免不必要的组织损伤; 3）通过证明该系统可以在90%的所有受试者中实现完全消融而不违反安全约束来证明动物模型中肿瘤和治疗边缘消融的安全性和有效性;以及4）在人体体内评价所开发的超声波束像差校正和温度测量技术，以证明所开发的技术在人类乳房中有效。该项目提出的创新对于MRgHIFU安全无创治疗乳腺癌至关重要，并将为I期临床试验的成功奠定基础。这项新技术将为患有局部乳腺癌的女性提供一种新的非侵入性治疗选择。

DESCRIPTION (provided by applicant): Breast cancer remains an important disease, adversely affecting a large population of women. The number of women diagnosed with breast cancer has continued to rise. While the majority of patients survive the disease, minimizing any disability or disfigurement as a result of treatment is very important to the patient's future qualty of life. Despite more sensitive MRI methods to detect breast lesions and new minimally invasive conservative forms of therapy, there still remains significant room for improvement in both imaging and therapy. MRI-guided high intensity focused ultrasound (MRgHIFU) has the potential to provide completely non-invasive therapy of localized lesions in the breast. This proposal addresses the remaining limitations that keep MRgHIFU from achieving its potential to non-invasively treat localized breast cancer. Building on an innovative breast-specific MRgHIFU system developed in an academic/industrial partnership led by scientists in the Utah Center for Advanced Imaging Research, the College of Engineering, and School of Medicine, this project will validate the system for rapid, efficacious, and safe non-invasive treatment of localized breast lesions with MRgHIFU. The project consists of four Specific Aims: 1) develop patient-specific methods of ultrasound beam aberration correction to improve ultrasound focus localization in the heterogeneous breast; 2) develop efficient methods for temperature measurement in the adipose and aqueous tissues of the heterogeneous breast to properly monitor the MRgHIFU treatment procedure thereby ensuring complete tumor ablation and avoiding unwanted tissue damage; 3) demonstrate safety and efficacy of tumor and treatment margin ablation in an animal model by proving the system can achieve complete ablation in 90% of all subjects without violating safety constraints; and 4) evaluate the developed ultrasound beam aberration correction and temperature measurement techniques in vivo in humans to demonstrate that the developed techniques are effective in human breasts. The innovations proposed in this project are critical for the safe non-invasive treatment of breast cancer with MRgHIFU and will lay the foundation for a successful phase I clinical trial. This new technology will provide a new, non-invasive treatment option for women with localized breast cancer.