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。虽然大多数患者都能存活下来，但尽量减少因治疗而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）有可能为乳房局部病变提供完全无创治疗。该建议解决了MRgHIFU在非侵入性治疗局限性乳腺癌方面的局限性。该项目建立在一个创新的乳房特异性MRgHIFU系统的基础上，该系统是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/工业合作伙伴关系开发的，该项目将验证该系统使用MRgHIFU快速、有效、安全、无创地治疗局部乳房病变。该项目包括四个具体目标：1)开发针对患者的超声束像差校正方法，以提高异质乳腺超声病灶的定位；2)开发有效的方法来测量非均匀乳腺脂肪和水组织的温度，以适当地监测MRgHIFU治疗过程，从而确保肿瘤完全消融并避免不必要的组织损伤；3)在动物模型中证明肿瘤和治疗边缘消融的安全性和有效性，证明该系统可以在不违反安全约束的情况下在90%的受试者中实现完全消融；4)对已开发的超声光束像差校正和人体体内温度测量技术进行评估，证明所开发的技术对人体乳房是有效的。本项目提出的创新对于MRgHIFU安全无创治疗乳腺癌至关重要，将为成功开展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妇女提供一种新的、非侵入性的治疗选择。

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.