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

描述（由申请人提供）：乳腺磁共振成像（MRI）与传统的乳腺成像方式（X射线乳腺摄影和超声）相比具有一些明显的优势。乳腺MRI在检测乳腺癌方面的灵敏度至少是乳房X线摄影或超声的两倍，并且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，美国癌症协会宣布了新的监测指南，其中包括对已知有乳腺癌高风险的妇女进行年度MRI筛查。因此，许多病变只能通过MRI早期检测到，因此需要MRI引导活检进行诊断。MR图像引导活检存在主要障碍，包括MRI扫描仪的高磁场环境和成像过程中患者无法接近。结果是MRI用于识别病变，但是活检必须在磁体的孔之外盲目地进行，而没有实时图像引导，导致更高的错误可能性、MRI引导活检的更高的活检/病理学不一致率以及重复活检的需要。拟议的工作旨在开发和商业化MRI辅助系统，以使磁共振图像引导乳腺活检（MR-IGB）完全在MRI扫描仪的孔内进行实时MR成像引导。该第一阶段工作将证明紧凑型多轴机器人控制定位器机制的技术可行性，该定位器机制将在高场闭孔MRI扫描仪中运行，因为这些扫描仪主导当前的乳腺MRI程序。总的努力将涉及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的开发。当患者被定位在MRI扫描仪的孔中时，机器人控制的机制将允许介入医生规划、监测和交互式微调乳房的高度可变形组织中的病变的活检轨迹。机器人IGB定位器机制将由介入医生从远程医生工作站驱动，其中活检轨迹规划以及实际穿刺器插入可以在实时成像引导下执行。开发将通过利用该团队先前开发的经过验证的乳房线圈设计，扩展先前在IGB机制设计和机器人致动器开发方面的工作，并集成先进的实时MRI，扫描仪控制和为其他更严格的应用开发的先进可视化软件平台来简化。将使用组织模拟体模进行1.5 T磁体的I期测试，以量化系统的操作特性，并使用正常人类志愿者评估同步成像期间机器人驱动对图像质量的影响。 公共卫生相关性：对于社会而言，成功证明磁共振成像引导介入（MR-IGI）新方法（如乳腺活检）的临床效用显著改善的潜力可能会导致更有效和更准确的手术，更低的手术成本，并可能改善更多患者对MRI技术的上级软组织成像能力的访问。所提出的技术使用MRI兼容机器人、实时MRI接口和计算机控制，以使介入手术能够在同步成像期间在扫描仪孔内完成，并对手术进行交互式控制。可视化和控制技术的数字化特性提供了MR-IGI程序远程遥控的进一步潜在受益，从而将稀缺的专业临床技能扩展到偏远和/或服务不足的人群。具体而言，改善乳腺活检新MR-IGI技术的使用可能会提高乳腺癌筛查的参与水平。乳腺癌筛查无论是乳房X线摄影或MRI目前代表了最有效的手段乳腺癌早期检测。随着时间的推移，额外的好处可能包括对MRI检测到的病变的不那么积极的建议，更重要的是，一般乳腺癌检测，诊断和治疗的模式转变。

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.