MRI-GUIDED ROBOTIC BREAST CANCER INTERVENTIONS

描述（由申请人提供）：本研究的目的是证明MRI引导下乳腺癌诊断和治疗的可行性，并指明方向。这项工作将通过整合实时磁共振成像和诊断/治疗探头的精确放置/监测来解决基于MRI的乳腺癌干预措施的几个迫切需求。乳腺MRI虽然在检测癌症方面非常有效，但尚未产生用于活检或局部治疗的有效方法。通过开发一个完全兼容MRI的机器人探头放置系统，可以通过MRI实时监测，许多程序的准确性和精度可以大大提高。此外，当患者在扫描仪内时执行程序可以大幅减少程序时间，为患者和医疗保健提供者提供增加的患者舒适度和降低的成本。本I期提案的目的是设计一种综合器械和程序，将无创MR诊断与微创MR引导穿刺活检结合起来。这是生物工程公司的布莱克·拉森和J·托马斯·沃恩博士的一项新的冒险，一家致力于MRI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技术、定制MR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），机器人放置装置在放置活检针或其他探针时将具有前所未有的灵活性。使用定制MR接收器线圈，申报的微创介入系统将利用MRI提供的3D信息，以允许在体内进入乳腺组织时具有前所未有的灵活性。该第一阶段项目的成功成果将是一个全功能原型系统，包括一个机器人放置设备，一个专用的MR线圈和软件来控制系统。可行性将通过在明尼苏达大学磁共振研究中心的4特斯拉（T）MRI扫描仪中对乳房体模进行多次准确、精确和安全的图像引导穿刺活检来证明。未来的II期计划将包括图像引导活检、标记放置和治疗（如冷冻消融、射频（RF）消融和经皮病变切除系统）的多中心人体研究。这项研究将为MRI引导的诊断和治疗提供一个可行的平台，可以更准确和有用地诊断和治疗使用X射线乳腺摄影或超声波不可见的乳腺肿瘤。通过使用实时探头定位，与包含手术规划、探头放置、放置验证以及通常必要的重新调整的当前手术相比，手术时间将显著减少。除了增加患者的舒适度外，这种缩短的手术时间还节省了大量成本，这将使乳房MRI更适用于年轻女性和那些目前难以获得保险报销的家族史。

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.