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（由适用提供）：在过去的十年中，磁共振成像（MRI）已成为检测，诊断和管理乳腺癌的重要工具。但是，MRI指导性介入程序的可用性和可靠性落后了。目前，超声（US）图像引导的乳房活检受到许多临床医生的MRI检测病变的青睐，因为它提供了活检过程的实时成像，并且使用相对容易且使用低成本。凭借我们，实时控制和监测活检的能力为病变采样的成功提供了高度的信心。但是，我们不提供MRI提供的检测灵敏度，这种方法需要在MRI和US套房之间洗牌，破坏工作流程并引起昂贵的延迟并增加患者的焦虑。更重要的是，许多乳腺病变只能通过MRI检测到，恶性率太高（22％），无法活检这些水平。在适当的情况下，也可以更有效地使用MRI来指导和监测肿瘤的微创热消融治疗。假设：我们假设使用实时MRI进行互动式控制和监测该程序的新介入机器人平台，用于指导MRI扫描仪内部的乳房活检程序，将允许干预主义者进行MRI引导的乳房活检MRI-MRI-sasted活检方法。初步数据：我们已经开发了一种机器人交互式MR成像引导活检（IMR-IGB）概念验证原型系统，并证明它可以通过在实时成像过程中通过MRI扫描仪内部的远程控制来工作。该原型系统已通过用于乳腺癌诊断和活检的典型MRI序列对影像质量的潜在不利影响进行了评估，并且由专家乳房MRI放射学家确定，很可能很可能适合于交互式指导性指导性乳房活检这些成像质量评估，这两种成像质量评估均在模仿的模拟幻影和受试者接受效率上，并且都可以接受。具体目的：我们的第一个目的是将IMR-IGB机器人系统硬件和控制软件的开发从概念验证原型中提高到适合进行初始人类临床评估的功能，安全性和操作完整性的水平。我们将通过系统，连续地靶向使用Robotics Control Subsystem的1 mM靶向精度，在模拟的活检程序中表现出功能性能在模拟活检过程中进行孔孔。我们的第二个目标是完全整合控制子系统：机器人技术和控制；扫描仪界面；以及AIM 1中开发的IMR-IGB硬件的临床工作站/用户界面。然后，我们将使用完全集成的系统重复AIM 1的功能性能演示，并成功完成放射科医生的前视体活检模拟。最终目的是获得FDA IDE批准，然后获得IRB批准的临床评估方案。