Non-Invasive MRI-Guided HIFU for Breast Cancer Therapy

描述(申请人提供)：乳腺癌仍然是一种重要的疾病，对大量妇女造成不利影响。被诊断患有乳腺癌的女性人数持续上升。虽然大多数患者都活了下来，但尽量减少因治疗而导致的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，以及新的微创保守治疗方式，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)具有为乳腺局部病变提供完全非侵入性治疗的潜力。这项建议解决了阻碍MRgHIFU实现其非侵入性治疗局部乳腺癌的潜力的剩余限制。在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/行业合作伙伴关系下开发的创新的乳房专用MRgHIFU系统的基础上，该项目将验证该系统对MRgHIFU用于快速、有效和安全的局部乳腺病变的非侵入性治疗。该项目由四个具体目标组成：1)开发针对特定患者的超声束像差校正方法，以改进异质乳房的超声焦点定位；2)开发高效的异质乳房脂肪和房水组织温度测量方法，以适当监控MRgHIFU治疗过程，从而确保肿瘤完全消融，避免有害组织损伤；3)通过动物模型展示肿瘤和治疗边缘消融的安全性和有效性，证明该系统可在不违反安全约束的情况下实现90%的受试者的完全消融；4)在人体体内对所开发的超声束像差校正和温度测量技术进行评估，以证明所开发的技术在人类乳房中是有效的。该项目中提出的创新对于使用MRgHIFU安全非侵入性治疗乳腺癌至关重要，并将为成功的I期临床试验奠定基础。这项新技术将为患有局限性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.