Pneumatic Drill and Robot for MRI-Guided Pediatrics Long Bone Biopsy

用于 MRI 引导儿科长骨活检的气动钻和机器人

• 批准号: 10689655
• 负责人: Kevin R. Cleary
• 金额: $ 51.4万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10689655
• 关键词: 3-Dimensional; Address; Affect; Anesthesia procedures; Anxiety; Biopsy; Blood; Bone Marrow; Bone neoplasms; Cadaver; Child; Childhood; Clinical; Clinical Management; Clinical Trials; Development; Diagnosis; Early treatment; Electricity; Engineering; Environment; Epiphysial cartilage; Evaluation; Exposure to; Family; Femur; Goals; Image Guided Biopsy; Institutional Review Boards; Intervention; Ionizing radiation; Leg; Leg Bones; Lesion; Life; Limb structure; Location; MRI Scans; Magnetic Resonance Imaging; Malignant Neoplasms; Medical center; Metals; Morphologic artifacts; Motion; Motor; Musculoskeletal; Needles; Operating Rooms; Operative Surgical Procedures; Patient Care; Patients; Pediatrics; Phase I Clinical Trials; Physicians; Physics; Procedures; Process; Radiation; Radiation exposure; Research Personnel; Risk; Robot; Robotics; Roentgen Rays; Sampling; Sampling Errors; Second Primary Neoplasms; Secure; Speed; System; Systems Integration; Technology; Testing; Thermal Ablation Therapy; Time; Tissue Sample; Tissues; Visualization; Work; X-Ray Computed Tomography; accurate diagnosis; bone; bone visualization; cancer clinical trial; cancer diagnosis; cancer therapy; clinical decision-making; clinical practice; design; early phase clinical trial; feasibility trial; image guided; improved; long bone; novel; optical sensor; pain symptom; patient population; pediatric patients; programs; rapid diagnosis; safety and feasibility; sample fixation; soft tissue; tibia; tool; trauma exposure; ultrasound

ABSTRACT The overall goal of this proposal is to complete a Phase I clinical trial of bone biopsy in pediatric patients using the novel MRI safe robot developed in our previous work. This robot will facilitate accurate MRI-guided bone biopsy and enable a new clinical workflow to reduce time to sampling and evaluation of tissue obtained from suspicious bone lesions. Our team has been developing small footprint MRI compatible robots to enable precision needle placement without radiation exposure to the patient or physician. In previous work, we designed, built, and evaluated a novel MRI safe needle guidance robot to provide accurate targeting of lesions in the long bones of the leg. The robot is actuated by unique pneumatic stepper motors and is entirely metal and electricity free, which allows it to work in the MRI environment completely free of artifacts. Targets were successfully reached using a long bone mockup in our 1.5T Siemens Aera MRI with an average 3D error of 1.39 mm and maximum error of 1.89 mm. We then completed a leg cadaver study in the tibia and femur. The cadaver study showed the need to develop an MRI-safe drill, which will be the focus of Specific Aim 1. We will follow these technical developments with additional cadaver studies in Specific Aim 2, followed by regulatory approvals and a clinical safety and feasibility trial in 20 pediatric patients in Specific Aim 3.Our specific aims are to: 1. Develop essential new components for our MRI-safe robot, specifically a new pneumatic power MRI safe bone biopsy drill and a support/fixation mechanism for securing the leg to the MRI table. 2. Complete additional cadaver studies to test the robot, drill, and mounting mechanism and confirm the proposed clinical workflow and the accuracy of the integrated system. 3. Obtain regulatory approvals for the Phase I clinical trial including FDA and IRB approval, followed by a safety and feasibility clinical trial of bone biopsy on 20 pediatric subjects using the MRI-safe robot and drill.

摘要 本提案的总体目标是完成儿科患者骨活检的I期临床试验 使用我们以前工作中开发的新型MRI安全机器人。这个机器人将有助于准确的MRI引导 骨活检，并实现新的临床工作流程，以减少取样和评估所获得的组织的时间 可疑的骨损伤我们的团队一直在开发小型MRI兼容机器人， 精确的针放置，而不会对患者或医生造成辐射暴露。在以前的工作中，我们 设计、构建并评估了一种新型MRI安全针引导机器人，以提供准确的病变靶向 在腿的长骨里该机器人由独特的气动步进电机驱动，完全是金属的 并且无电，这使得它可以在完全没有伪影的MRI环境中工作。目标是 使用我们的1.5T Siemens Aera MRI中的长骨模型成功达到，平均3D误差为 1.39 mm和最大误差为1.89 mm。然后，我们完成了胫骨和股骨的腿部尸体研究。的 尸体研究表明需要开发MRI安全钻，这将是特定目标1的重点。我们将 遵循这些技术发展，在Specific Aim 2中进行额外的尸体研究，然后进行监管 批准和临床安全性和可行性试验在20名儿科患者的具体目标3。我们的具体目标 是： 1.为我们的MRI安全机器人开发必要的新组件，特别是新的气动MRI安全机器人 骨活检钻和用于将腿固定到MRI台的支撑/固定机构。 2.完成额外的尸体研究，以测试机器人、钻头和安装机制，并确认 建议的临床工作流程和集成系统的准确性。 3.获得I期临床试验的监管批准，包括FDA和IRB批准，然后 使用MRI安全机器人和钻头对20名儿科受试者进行骨活检的安全性和可行性临床试验。