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

描述（由申请人提供）：磁共振成像（MRI）在过去十年中成为乳腺癌检测、诊断和治疗的重要工具。然而，MRI引导的介入手术的可用性和可靠性已经落后。目前，超声（US）图像引导乳腺活检是许多临床医生对mri检测病变的青睐，因为它提供了活检过程的实时成像，使用起来相对容易和低成本。有了US，实时控制和监测活检的能力为病变取样的成功提供了高度的信心。然而，美国不提供MRI的检测灵敏度，这种方法需要在MRI和美国套件之间轮换患者，扰乱工作流程，造成代价高昂的延误，增加患者的焦虑。更重要的是，许多乳腺病变只能通过MRI检测到，而且恶性率太高（22%），不能对这些病变进行活检。在适当的情况下，MRI也可以更有效地指导和监测肿瘤的微创热消融治疗。假设：我们假设一个新的介入机器人平台，用于在MRI扫描仪的孔内指导乳房活检程序，使用实时MRI对程序进行交互式控制和监测，将使介入医生比目前的MRI辅助活检方法更快、更准确地进行MRI引导的乳房活检。初步数据：我们开发了一种机器人交互式磁共振成像引导活检（iMR-IGB）概念验证原型系统，并证明它可以在实时成像期间通过远程控制在MRI扫描仪的孔内工作。该原型系统对用于乳腺癌诊断和活检的典型MRI序列成像质量的潜在不利影响进行了评估，并由乳腺MRI放射科专家确定非常适合交互式指导乳腺活检。这些成像质量评估在模拟组织和人类受试者志愿者中进行，发现成像质量在两种情况下都是可接受的。具体目标：我们的第一个目标是推进iMR-IGB机器人系统硬件和控制软件的开发，从概念验证原型到功能、安全性和操作完整性水平，适合进行初步的人体临床评估。我们将通过使用机器人控制子系统系统地连续瞄准一组典型病变位置，在1毫米的瞄准精度范围内，在模拟离体组织活检过程中演示功能性能。我们的第二个目标是充分整合控制子系统：机器人动力和控制；扫描仪接口;临床工作站/用户界面，在Aim 1中开发了iMR-IGB硬件。然后，我们将使用完全集成的系统来重复目标1的功能性能演示，并成功完成放射科医生的离体活检模拟。最终目标是获得FDA IDE批准，然后获得IRB批准用于临床评估的新方案。

DESCRIPTION (provided by applicant): Magnetic Resonance Imaging (MRI) has emerged in the past decade as an important tool for the detection, diagnosis and management of breast cancer. However, the availability and reliability of MRI guided interventional procedures have lagged behind. Currently, ultrasound (US) image-guided breast biopsy is favored by many clinicians for MRI-detected lesions, as it provides real-time imaging of the biopsy process and it is relatively easy and low cost to use. With US the ability to control and monitor the biopsy in real-time provides a high level of confidence regarding the success of lesion sampling. However, US does not provide the detection sensitivity offered by MRI and this approach requires shuffling patients between MRI and US suites, disrupting workflow and causing costly delays and increasing patient anxiety. More importantly, many breast lesions can only be detected with MRI and the malignancy rate is too high (22%) to not biopsy these lesions. Where appropriate, MRI could also be used more effectively to guide and monitor minimally invasive thermal ablation treatment of tumors. Hypothesis: We hypothesize that a new interventional robotic platform for guiding breast biopsy procedures inside the bore of the MRI scanner, using real-time MRI for interactive control and monitoring of the procedure, will allow interventionists to perform MRI guided breast biopsies much more quickly and more precisely than with current MRI-assisted biopsy methods. Preliminary Data: We have developed a robotic interactive MR Imaging Guided Biopsy (iMR-IGB) proof-of-concept prototype system and demonstrated that it can work by remote control inside the bore of an MRI scanner during real-time imaging. This prototype system has been assessed for potential adverse impacts on imaging quality with typical MRI sequences used for breast cancer diagnosis and biopsy, and was determined by expert breast MRI radiologists to be very likely suitable for interactively guiding breast biopsies These imaging quality assessments were performed with both tissue mimicking phantoms and with human subject volunteers, and imaging quality was found to be acceptable in both scenarios. Specific Aims: Our first aim is to advance the development of the iMR-IGB robotic system hardware and control software from proof-of-concept prototype to a level of functionality, safety and operational integrity suitable for performing initial human clinical evaluations. We wil demonstrate functional performance in-bore in simulated biopsy procedures with ex-vivo tissue by systematically and consecutively targeting an array of typical lesion locations within �1 mm targeting accuracy using the robotics control subsystem. Our second aim is to fully integrate the control subsystems: Robotics Power and Control; Scanner Interface; and Clinical Workstation/User Interface, with the iMR-IGB hardware developed in Aim 1. We will then use the fully integrated system to repeat the demonstration of functional performance from aim 1, and to successfully complete an ex-vivo biopsy simulation by a radiologist. The final aim is to acquire FDA IDE approval, then achieve IRB approval of a new protocol for clinical evaluations.