Development and testing of MRI-mediated radiofrequency ablation system and probes

MRI介导的射频消融系统和探头的开发和测试

• 批准号: 9200285
• 负责人: JEROME L ACKERMAN
• 金额: $ 74.91万
• 依托单位: ROBIN MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-05 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9200285
• 关键词: Ablation; American Society of Clinical Oncology; Animals; Area; Biopsy; Biopsy Specimen; Blood Vessels; Burn injury; Cadaver; Capital; Catheterization; Catheters; Clinical; Clinical Trials; Colorectal Cancer; Contracts; Detection; Development; Devices; Diagnostic; Effectiveness; Endoscopes; Endoscopy; Ensure; Equipment; Funding; Future; Goals; Grant; Guidelines; Heating; Hemorrhage; Human; Image; Imaging Techniques; Lead; Lesion; Life; MRI Scans; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of liver; Marketing; Mediating; Metastatic Neoplasm to the Liver; Methods; Mission; Modality; Monitor; National Comprehensive Cancer Network; Navigation System; Needles; Operative Surgical Procedures; Organ; Pain management; Patient-Focused Outcomes; Patients; Penetration; Performance; Phase; Pilot Projects; Primary Malignant Neoplasm of Liver; Primary carcinoma of the liver cells; Probability; Procedures; Radiofrequency Interstitial Ablation; Recovery; Research; Safety; Small Business Innovation Research Grant; Solid Neoplasm; Specimen; Speed; Structure; Surgical Management; System; Technology; Temperature; Testing; Therapeutic; Thermal Ablation Therapy; Time; Tissues; Translating; Ultrasonography; abstracting; base; chemotherapy; clinical practice; cohort; commercialization; cost; cost effective; curative treatments; experience; graphical user interface; health care delivery; human study; image guided; improved; improved outcome; injury prevention; liver transplantation; minimally invasive; novel; patient safety; prevent; soft tissue; success; therapy development; tissue phantom; tool; tumor; tumor ablation

Project Summary/Abstract Radiofrequency ablation (RFA) is a minimally invasive method used to treat solid tumors, commonly primary liver cancers and metastases, which are accessible percutaneously via a sharp needle. Imaging guidance, typically by ultrasound or CT, is required for probe placement, but these methods are incapable of monitoring the progress of the procedure. Additional imaging sessions are required to initially locate the tumor and to assess the effectiveness of the therapy. The overall goal of this project is to translate into clinical practice a novel MRI-mediated RFA therapy. In this method, RF energy is provided and controlled by the MRI scanner, eliminating the need for an external RF generator and a grounding pad. The MRI scanner additionally offers superior soft tissue contrast for tumor localization and real time guidance of RF probe placement using a commercial gradient-based navigation system. Additionally, monitoring of tissue (rather than probe) temperature is possible during the procedure, permitting immediate assessment of the success of the ablation. Eliminating the grounding pad reduces the possibility of patient burns, and therefore increases patient safety. An initial R21 exploratory grant funded basic discovery research into this technology, comprising theoretic, scientific and technical development of MRI-mediated RFA, resulting in the demonstration of proof of principle in phantoms, tissue specimens, animal cadavers and live animals. The purpose of the current project is to translate these basic findings into a safe and practical system for clinical use, and to conduct a human clinical pilot project to assess if a full clinical trial is warranted. Specific aims include: 1- Develop integrated biopsy and RFA probes for MRI-mediated RF ablation. 2 - Optimize the performance of MRI-mediated RFA in phantom study. 3 - Optimize performance and safety of MRI-mediated biopsy and RFA in an animal study. 4 - Conduct the required regulatory activities needed to enable human study of the system. 5 - Perform pilot study in humans with liver cancer to be treated by chemotherapy. The long term goal of the research is to develop a time-efficient, cost-effective, minimally invasive “one-stop shop” treatment for solid tumors treatable by thermal ablation. If successful, it will provide a powerful diagnostic and therapeutic tool that can be used on any MRI scanner with low cost disposable devices and without the need to add major external apparatus. This is expected to facilitate the use of MRI-guided RFA to treat a wide range of tumors as a replacement for more invasive and more costly surgical management, contributing to the PHS mission of improving health care delivery while reducing cost and patient discomfort.

项目摘要/摘要 射频消融术是一种微创方法，用于治疗实体肿瘤，通常是原发肿瘤。 肝癌和转移，可以通过尖锐的针经皮接触到。成像制导， 通常是通过超声波或CT，需要放置探头，但这些方法不能监测 手术的进度。需要额外的成像会议来初步定位肿瘤并 评估治疗的有效性。 该项目的总体目标是将一种新的MRI介导的RFA疗法转化为临床实践。在这 方法中，射频能量由MRI扫描仪提供和控制，不再需要外部射频 发电机和接地垫。核磁共振扫描仪还为肿瘤提供了卓越的软组织对比度 使用基于商业梯度的导航定位和实时引导射频探头放置 系统。此外，在手术过程中可以监测组织(而不是探头)温度， 允许立即评估消融的成功程度。取消接地垫可减少 有可能导致患者烧伤，因此增加了患者的安全性。 最初的R21探索性拨款资助了对这项技术的基本发现研究，包括理论上的， MRI介导的RFA的科学技术发展，导致了原理证明的论证 在幻影、组织标本、动物身体和活动物中。当前项目的目的是 将这些基本发现转化为安全和实用的临床使用系统，并进行人类临床 评估是否有必要进行全面临床试验的试点项目。 具体目标包括： 1-开发用于MRI介导式射频消融的综合活检和RFA探头。 2-在体模研究中优化MRI介导的RFA的性能。 3-在动物研究中优化MRI介导的活组织检查和RFA的性能和安全性。 4-开展必要的监管活动，以便能够对系统进行人体研究。 5-对将接受化疗的肝癌患者进行初步研究。 这项研究的长期目标是开发一种省时、经济、微创的“一站式” “商店”治疗可通过热消融治疗的实体肿瘤。如果成功，它将提供一个强大的诊断 和治疗工具，可以在任何具有低成本一次性设备的MRI扫描仪上使用，而不需要 需要增加主要的外部设备。这有望促进使用MRI引导的RFA治疗广泛的 一系列肿瘤作为更具侵入性和更昂贵的外科治疗的替代品，有助于 小灵通的使命是改善医疗保健服务，同时降低成本和患者的不适感。