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

基本信息

批准号：
10348193
负责人：
Kevin R. Cleary
金额：
$ 51.12万
依托单位：
CHILDREN'S RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
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/10348193
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 Technology Testing Thermal Ablation Therapy Time Tissue Sample Tissues Visualization Work X-Ray Computed Tomography accurate diagnosis base 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

项目摘要

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.

抽象的该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之前工作中开发的新型 MRI 安全机器人。该机器人将有助于准确的 MRI 引导骨活检并启用新的临床工作流程，以减少对所获得的组织进行采样和评估的时间来自可疑的骨病变。我们的团队一直在开发小型 MRI 兼容机器人，以实现精确的针放置，不会使患者或医生受到辐射照射。在之前的工作中，我们设计、建造并评估了一种新型 MRI 安全针引导机器人，以提供准确的病灶定位在腿部的长骨中。该机器人由独特的气动步进电机驱动，并且完全由金属制成并且无电，这使得它可以在完全无伪影的 MRI 环境中工作。目标是在我们的 1.5T 西门子 Aera MRI 中使用长骨模型成功实现了平均 3D 误差 1.39 毫米，最大误差为 1.89 毫米。然后我们完成了腿部尸体胫骨和股骨的研究。这尸体研究表明需要开发一种 MRI 安全钻头，这将是具体目标 1 的重点。我们将遵循这些技术发展，在具体目标 2 中进行额外的尸体研究，然后进行监管具体目标 3 中的批准以及对 20 名儿科患者进行的临床安全性和可行性试验。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，特别是新型气动 MRI 安全机器人骨活检钻和用于将腿固定到 MRI 台上的支撑/固定机构。 2. 完成额外的尸体研究以测试机器人、钻头和安装机构并确认提出了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，然后是使用 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。