MRI-GUIDED ROBOTIC BREAST CANCER INTERVENTIONS

描述(由申请人提供)：这项研究的目的是论证MRI引导乳腺癌诊断和治疗的可行性，并为其指明方向。这一努力将通过集成实时磁共振成像和诊断/治疗探头的精确放置/监测来满足基于MRI的乳腺癌干预中的几个迫切需求。虽然乳腺MRI在检测癌症方面非常有效，但无论是活组织检查还是局部治疗，都尚未产生一种有效的方法。通过开发一种完全与MRI兼容的机器人探头放置系统，可以由MRI实时监控，许多手术的准确性和精密度可以显著提高。此外，当患者在扫描仪内时进行手术可以大幅减少手术时间，增加患者舒适度，并降低患者和医疗保健提供者的成本。这个第一阶段提案的目的是设计一种综合的设备和程序，将非侵入性MR诊断与微创MR引导的针吸活组织检查相结合。这是生物工程公司的布莱克·拉森和J·托马斯·沃恩博士的一项新业务，该公司是一家致力于核磁共振相关诊断和治疗的小企业。我们将开发用于远程控制设备的机器人、定制的磁共振接收器线圈和适当的控制软件。通过使用五个位置自由度(DOF)，机器人放置设备在放置活检针或其他探头时将具有前所未有的灵活性。使用定制的MR接收器线圈，拟议的微创介入系统将利用MRI提供的3D信息，在活体访问乳房组织方面具有前所未有的灵活性。这个第一阶段项目的成功成果将是一个全功能的原型系统，包括一个机器人贴装装置、一个专用的MR线圈和控制系统的软件。通过在明尼苏达大学磁共振研究中心的4特斯拉(T)核磁共振扫描仪上对乳房模体进行多次准确、精确和安全的图像引导针吸活检，将证明其可行性。未来的第二阶段计划将包括图像引导活检、标记物放置和冷冻消融、射频消融和经皮病变清除系统等治疗的多点人体研究。这项研究将为MRI引导的诊断和治疗提供一个可行的平台，使人们能够更准确、更有用地诊断和治疗使用X光乳房X光照相或超声波看不到的乳腺肿瘤。通过使用实时探头定位，与当前反复进行程序规划、探头放置、放置验证以及经常必要的重新调整的程序相比，程序时间将显著减少。除了增加患者的舒适度外，这种减少的手术时间还带来了显著的成本节约，这将使年轻女性和那些有家族病史但目前难以获得保险报销的人更容易获得乳房MRI。

DESCRIPTION (provided by applicant): The objective of this research is to demonstrate the feasibility of, and point the way toward, MRI-guided breast cancer diagnosis and therapy. This effort will address several pressing needs in MRI-based breast cancer interventions by integrating real-time magnetic resonance imaging and precision placement/monitoring of diagnostic/therapeutic probes. Breast MRI, while extremely effective in detecting cancers, has yet to produce an efficient method for either biopsies or localized therapies. By developing a fully MRI-compatible robotic probe placement system that can be monitored by MRI in real-time, the accuracy and precision of many procedures can be considerably improved. In addition, performing the procedure while the patient is inside the scanner can provide a drastic reduction in procedure time, providing increasing patient comfort and decreased cost to patients and healthcare providers. The aim of this Phase I proposal is to engineer a comprehensive device and procedure coupling non-invasive MR diagnostics with minimally-invasive MR-guided needle biopsy. This is a new venture of Blake Larson and Dr. J. Thomas Vaughan of Bioengineering, Inc., a small business dedicated to MRI-related diagnostics and therapeutics. We will develop robotics for remote control of the device, custom MR receiver coils, and appropriate control software. By using five positional degrees of freedom (DOF), the robotic placement device will have unprecedented flexibility in placing a biopsy needle or other probes. Using the custom MR receiver coil, the proposed minimally-invasive, interventional system will make use of 3D information provided by MRI to allow unprecedented flexibility in accessing the breast tissue in vivo. A successful outcome of this Phase I project will be a full functional prototype system consisting of a robotic placement device, a dedicated MR coil, and software to control the system. Feasibility will be demonstrated by performing multiple accurate, precise, and safe image-guided needle biopsies on breast phantoms in a 4 tesla (T) MRI scanner at the University of Minnesota's Center for Magnetic Resonance Research. Future Phase II plans will include multi-site human studies of image-guided biopsies, marker placement, and therapies such as cryoablation, radiofrequency (RF) ablation, and percutaneous lesion removal systems. This research will produce a viable platform for MRI-guided diagnostics and therapeutics that will allow more accurate and useful diagnosis and therapy of breast tumors that are not visible using x-ray mammography or ultrasound. By using real-time probe positioning, procedure time will be significantly reduced as compared to the current procedures that iterate with procedure planning, probe placement, placement verification, and often necessary readjustments. In addition to increasing patient comfort, this reduced procedure time presents significant cost savings that will make breast MRI more available to young women and those with family histories that currently have difficulty with insurance reimbursements.