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：
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
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/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

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小儿患者骨活作活检的I期临床试验使用新颖的MRI安全机器人在我们以前的工作中开发。该机器人将促进准确的MRI引导骨骼活检并启用新的临床工作流程，以减少对获得的组织的抽样和评估的时间来自可疑的骨骼病变。我们的团队一直在开发小型足迹MRI兼容机器人以启用精确的针头放置，而没有辐射暴露于患者或医师。在以前的工作中，我们设计，建造和评估了一种新型的MRI安全针头指导机器人，以提供精确的病变靶向在腿的长骨头。机器人由独特的气动步进电动机驱动，完全是金属和无电力，这使其可以在MRI环境中工作，完全没有文物。目标是在我们的1.5T Siemens AERA MRI中成功使用了长骨模型，平均3D误差为 1.39毫米，最大误差为1.89毫米。然后，我们完成了一项在胫骨和股骨的腿尸体研究。这尸体研究表明，有必要开发MRI-SAFE训练，这将是特定目标的重点。我们将遵循这些技术发展，并在特定目标2中进行其他尸体研究，然后进行监管特定目的的20名儿科患者的批准以及临床安全和可行性试验3.我们的特定目的是： 1。为我们的MRI-SAFE机器人开发必不可少的新组件，特别是新的气动Power MRI安全骨骼活检钻头和用于将腿固定到MRI表的支撑/固定机制。 2。完成其他尸体研究以测试机器人，钻孔和安装机制并确认拟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，然后是使用MRI-SAFE机器人和钻头对20个儿科受试者进行骨骼活检的安全性和可行性临床试验。