Interactive MR Image Guided Intervention (iMR-IGI) for Breast Applications

描述(申请人提供)：与传统的乳房成像方式(x射线乳房X光摄影和超声波)相比，乳房的磁共振成像(MRI)具有一些明显的优势。乳腺MRI已被证明在检测乳腺癌方面的敏感性至少是乳房X光照相或超声的两倍，并可以提供真正的三维体积成像，使临床医生能够以特殊的软组织对比度成像，以便在周围结构的背景下可视化肿瘤。2007年，美国癌症协会公布了新的监测指南，其中包括对已知的乳腺癌高危女性进行年度核磁共振检查。因此，许多病变只能通过MRI才能早期发现，因此需要MRI引导下的活检才能诊断。磁共振成像引导活检存在主要障碍，包括磁共振扫描仪的高磁场环境和成像过程中患者无法接近。其结果是，MRI用于识别病变，但活检必须在磁铁的孔外盲目进行，而没有实时图像引导，从而导致更大的出错可能性，MRI引导的活检/病理不符合率更高，以及需要重复活检。这项拟议的工作旨在开发一种MRI辅助系统并将其商业化，以实现磁共振图像引导的乳腺活检(MR-IGB)完全在MRI扫描仪的内孔内进行，并实时进行MR成像引导。这项第一阶段的工作将展示一种紧凑的多轴机器人控制的定位器机构的技术可行性，该定位器将在高场闭孔MRI扫描仪中运行，因为这些扫描仪主导着当前的乳房MRI程序。总的努力将包括开发与MRI兼容的活检机制、精密机器人引导系统，以及集成成像、机器人控制和医生干预的医生工作站软件界面。当患者被放置在核磁共振扫描仪的孔中时，机器人控制的机构将允许干预者计划、监控和交互地微调乳腺高度变形组织中的病变的活检轨迹。机器人IGB定位器机构将由干预者从远程医生工作站驱动，在远程医生工作站，活检轨迹规划以及实际的套管针插入可以在实时成像指导下执行。通过利用该团队以前开发的成熟的乳房线圈设计，扩展先前在IGB机构设计和机器人执行器开发方面的工作，并整合为其他更严格的应用开发的先进实时核磁共振、扫描仪控制和先进的可视化软件平台，将简化开发流程。将使用1.5T磁体进行I阶段测试，使用组织模拟模型来量化系统的操作特征，并使用正常的人类志愿者来评估在同时成像期间机器人驱动对图像质量的影响。 与公众健康相关：对于社会而言，成功地证明磁共振成像引导干预(MR-IGI)新方法(如乳腺活检)的临床实用性显著提高的潜力，可能会导致更高效、更准确的程序、更低的程序成本，并有可能改善更多患者获得MRI技术卓越软组织成像能力的机会。这项拟议的技术使用了与MRI兼容的机器人技术、实时MRI接口和计算机控制，使介入性程序能够在并行成像期间在扫描仪内孔内完成，并对程序进行交互控制。可视化和控制技术的数字本质提供了远程远程控制MR-IGI程序的进一步潜在好处，从而将稀缺的专门临床技能的覆盖范围扩大到偏远和/或服务不足的人群。具体地说，更好地利用新的MR-IGI技术进行乳腺活检可能会增加乳腺癌筛查的参与度。乳癌筛查无论是乳房X光检查还是核磁共振检查，都是目前乳腺癌早期发现最有效的手段。随着时间的推移，其他好处可能包括对MRI检测到的病变提出不那么激进的建议，更重要的是，总体上改变乳腺癌检测、诊断和治疗的范式。

DESCRIPTION (provided by applicant): Magnetic Resonance Imaging (MRI) of the breast has some clear advantages over traditional breast imaging modalities (x-ray mammography and ultrasound). Breast MRI has been shown to be at least twice as sensitive as mammography or ultrasound in detection of breast cancer and can provide true three dimensional volumetric imaging, enabling clinicians to image with exceptional soft tissue contrast for visualization of tumors in the context of the surrounding structures. In 2007 the American Cancer Society announced new surveillance guidelines that include annual MRI screening for women known to be at high risk for breast cancer. As a consequence, many lesions are detected early only by MRI and thus require MRI guided biopsy for diagnosis. There are major barriers to MR Image Guided Biopsy, including the high magnetic field environment of the MRI scanner and inaccessibility of the patient during imaging. The result is that MRI serves to identify the lesions, but the biopsy must proceed blindly outside the bore of the magnet, without real-time image guidance, resulting in higher potential for error, higher biopsy/pathology discordance rates for MRI- guided biopsies and the need to repeat biopsies. The proposed work intends to develop and commercialize an MRI accessory system to enable Magnetic Resonance Image Guided breast Biopsy (MR-IGB) completely inside the bore of the MRI scanner with real-time MR imaging guidance. This Phase-I work will demonstrate the technical feasibility of a compact, multi-axis robotically controlled positioner mechanism that will operate in a high-field, closed bore MRI scanner, as these scanners dominate current breast MRI procedures. The total effort will involve the development of the MRI compatible biopsy mechanism, the precision robotics guidance system, and a Physician Workstation software interface that integrates imaging, robotics control and physician intervention. With the patient positioned in the bore of the MRI scanner, the robotically controlled mechanism will allow an interventionist to plan, monitor, and interactively fine tune the biopsy trajectory for lesions in the highly deformable tissue of the breast. The robotic IGB positioner mechanism will be driven by the interventionist from the remote Physician Workstation where the biopsy trajectory planning, as well as the actual trocar insertion, can be performed under real-time imaging guidance. Development will be streamlined by utilizing a proven breast coil design previously developed by the team, extending previous work on the IGB mechanism design and robotic actuator development, and integrating advanced real-time MRI, scanner control and advanced visualization software platforms developed for other, more rigorous applications. Phase-I testing with a 1.5 T magnet will be done using tissue mimicking phantoms to quantify the operational characteristics of the system, and with normal human volunteers to assess the impact on image quality of robotics actuation during concurrent imaging. PUBLIC HEALTH RELEVANCE: For society, successful demonstration of the potential for significantly improved clinical utility of a new approach for Magnetic Resonance Imaging Guided Interventions (MR-IGI), such as breast biopsies, may result in more efficient and more accurate procedures, lower cost procedures, and potentially improved access for more patients to the superior soft tissue imaging capability of MRI technology. The proposed technology uses MRI compatible robotics, a real-time MRI interface and computer control to enable interventional procedures to be done inside the scanner bore during concurrent imaging and with interactive control of the procedure. The digital nature of the visualization and control technology offers the further potential benefit of long-distance remote control of MR-IGI procedures, thereby broadening the reach of scarce specialized clinical skills to remote and/or underserved populations. Specifically, improved access to the new MR-IGI technology for breast biopsies may increase levels of participation in breast cancer screening. Breast Cancer screening with either mammography or MRI currently represents the most effective means for breast cancer early detection. In time, additional benefits could include less aggressive recommendations for MRI detected lesions and, more importantly, a paradigm shift for breast cancer detection, diagnosis and treatment in general.