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

适用于乳腺应用的交互式 MR 图像引导干预 (iMR-IGI)

• 批准号: 8986773
• 负责人: RAYMOND D HARTER
• 金额: $ 46.57万
• 依托单位: MARVEL MEDTECH, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-19 至 2017-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8986773
• 关键词: Advanced Development; Anxiety; Authorization documentation; Biological; Biopsy; Blinded; Brain; Breast; Breast Cancer Detection; Breast Cancer Early Detection; Breast Cancer therapy; Breast biopsy; Cancer Detection; Cancer Etiology; Cause of Death; Ceramics; Cessation of life; Clinical; Clinical Skills; Computer software; Data; Detection; Development; Diagnosis; Diagnostic; Environment; Fatty acid glycerol esters; Freedom; Health; High Risk Woman; Human; Image; Image Guided Biopsy; Imagery; Imaging technology; Improve Access; Institutional Review Boards; Intervention; Invaded; Investments; Lesion; Location; Magnetic Resonance Imaging; Malignant Neoplasms; Mammary Ultrasonography; Mammography; Manufacturer Name; Mechanics; Methods; Monitor; Nature; Noise; Patients; Peptide Hydrolases; Performance; Phase; Plug-in; Procedures; Process; Prostate; Protocols documentation; Readiness; Recommendation; Research; Robotics; Safety; Sampling; Signal Transduction; Staging; System; Systems Integration; Technology; Thermal Ablation Therapy; Time; Tissues; Trocars; Ultrasonography; Underserved Population; Universities; Validation; Wisconsin; Woman; Work; angiogenesis; breast cancer diagnosis; breast lesion; clinical application; cost; design; digital; experience; human subject; image guided; image guided intervention; imaging modality; improved; magnetic field; malignant breast neoplasm; minimally invasive; operation; pre-clinical; prototype; radiologist; research clinical testing; robot control; simulation; success; tool; tumor; volunteer; years of life lost

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.

描述(由申请人提供)：磁共振成像(MRI)在过去十年中已成为检测、诊断和治疗乳腺癌的重要工具。然而，MRI引导的介入手术的可用性和可靠性一直滞后。目前，超声(US)图像引导下的乳腺活检因其提供了活检过程的实时成像以及相对简单和低成本而受到许多临床医生的青睐。使用US，实时控制和监控活检的能力为病变采样的成功提供了高度的信心。然而，美国不提供MRI提供的检测灵敏度，这种方法需要患者在MRI和US套件之间切换，扰乱工作流程，造成代价高昂的延误，并增加患者的焦虑。更重要的是，许多乳腺病变只能通过MRI才能发现，而且恶性率太高(22%)，不能不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，一种新的介入性机器人平台，用于指导MRI扫描仪内孔内的乳腺活检程序，使用实时MRI对程序进行交互控制和监控，将使干预者能够比目前的MRI辅助活检方法更快、更准确地进行MRI引导的乳腺活检。初步数据：我们开发了一个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，并演示了它可以在实时成像期间通过远程控制在MRI扫描仪的内孔内工作。这个原型系统已经使用用于乳腺癌诊断和活检的典型MRI序列对成像质量的潜在不利影响进行了评估，并被专业乳腺MRI放射科医生确定非常可能适合于交互指导乳腺活检。这些成像质量评估是在组织模拟模型和人类受试者志愿者的情况下进行的，并且发现在两种情况下成像质量都是可以接受的。具体目标：我们的第一个目标是推动IMR-IGB机器人系统硬件和控制软件的开发，从概念验证原型发展到适合进行初步人类临床评估的功能、安全和操作完整性水平。我们将展示在模拟活体组织活检过程中的功能表现，通过使用机器人控制子系统在�1 mm的定位精度内系统和连续地瞄准一组典型的病变位置。我们的第二个目标是将控制子系统：机器人动力和控制、扫描仪界面和临床工作站/用户界面与AIM 1中开发的IMR-IGB硬件完全集成。然后，我们将使用完全集成的系统重复AIM 1中的功能性能演示，并成功完成放射科医生的体外活组织检查模拟。最终目标是获得FDA IDE的批准，然后获得IRB对临床评估新方案的批准。