Non-Invasive MRI-Guided HIFU for Breast Cancer Therapy

非侵入性 MRI 引导 HIFU 用于乳腺癌治疗

• 批准号: 8579530
• 负责人: DENNIS L PARKER
• 金额: $ 50.32万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-21 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8579530
• 关键词: Ablation; Acoustics; Address; Adipose tissue; Adverse event; Affect; Algorithms; Animal Model; Animals; Breast; Breast Cancer Treatment; Burn injury; Classification; Deposition; Detection; Devices; Diagnosis; Disease; Engineering; Ensure; Fat necrosis; Fatty acid glycerol esters; Fibroadenoma; Focused Ultrasound Therapy; Foundations; Frequencies; Future; Goals; Human; Human Volunteers; Hybrids; Image; Implant; Life; Local Therapy; Localized Lesion; Magnetic Resonance Imaging; Mammary Gland Parenchyma; Maps; Measurement; Measures; Methods; Modeling; Monitor; Motion; Normal tissue morphology; Organ; Oryctolagus cuniculus; Pain; Patients; Pattern; Phase I Clinical Trials; Physiologic pulse; Population; Predictive Value; Procedures; Property; Protocols documentation; Protons; Radiation; Research; Safety; Scientist; Skin; System; Techniques; Temperature; Tissues; Treatment Efficacy; Ultrasonography; Universities; Update; Utah; Woman; aqueous; base; breast lesion; cancer therapy; college; disability; good laboratory practice; improved; in vivo; innovation; interest; malignant breast neoplasm; medical schools; minimally invasive; new technology; novel; pre-clinical; preclinical study; public health relevance; reconstruction; skin lesion; tumor

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.

描述（由申请人提供）：乳腺癌仍然是一种重要的疾病，对大量女性产生不利影响。被诊断患有乳腺癌的女性人数持续增加。虽然大多数患者都能存活下来，但尽量减少治疗造成的残疾或毁容对于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，但成像和治疗仍然存在很大的改进空间。 MRI 引导的高强度聚焦超声 (MRgHIFU) 有潜力为乳腺局部病变提供完全无创的治疗。该提案解决了 MRgHIFU 无法发挥其非侵入性治疗局部乳腺癌潜力的剩余限制。该项目以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创新型乳腺特异性 MRgHIFU 系统为基础，将验证该系统是否能够通过 MRgHIFU 快速、有效且安全地非侵入性治疗局部乳腺病变。该项目包括四个具体目标：1）开发针对患者的超声束像差校正方法，以改善异质乳腺中的超声焦点定位； 2）开发有效的异质乳腺脂肪和水组织温度测量方法，以正确监测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) 通过证明系统可以在不违反安全限制的情况下对 90% 的受试者实现完全消融，证明动物模型中肿瘤和治疗边缘消融的安全性和有效性； 4）在人体体内评估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对人类乳房有效。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限性乳腺癌的女性提供一种新的非侵入性治疗选择。