Platform for MR-Guided Neurotherapeutic Drug Delivery

MR 引导神经治疗药物输送平台

• 批准号: 8906301
• 负责人: Edward Ray Barker
• 金额: $ 93.9万
• 依托单位: INSERT, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-27 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8906301
• 关键词: Address; Advocate; Algorithms; Animal Model; Back; Bilateral; Biopsy; Brain; Brain Neoplasms; Brain imaging; Brain region; Businesses; Cadaver; Cannulas; Catheters; Collaborations; Complex; Computer Interface; Data; Development; Devices; Drug Delivery Systems; Drug Monitoring; Drug Targeting; Effectiveness; Ensure; Environment; Failure; Family suidae; Feedback; Gel; Gene Delivery; Goals; Growth; Head; Healthcare; Hereditary Disease; Heterogeneity; Human; Image; Imagery; Infusion procedures; Institutional Review Boards; Investigation; Lead; Location; Magnetic Resonance Imaging; Malignant Neoplasms; Maps; Mental disorders; Modeling; Monitor; Monkeys; Multiple Sclerosis; Nature; Neurodegenerative Disorders; Neurosurgeon; Neurosurgical Procedures; Operating Rooms; Operative Surgical Procedures; Outcome; Parkinson Disease; Patients; Performance; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physiologic pulse; Positioning Attribute; Pre-Clinical Model; Procedures; Protocols documentation; Provider; Regulation; Reporting; Research Design; Risk; Role; Safety; Solutions; Spatial Distribution; Speed; Surgeon; System; Techniques; Technology; Testing; Therapeutic; Therapeutic Agents; Therapy trial; Time; Tracer; Training; Uncertainty; Universities; Update; Validation; Wisconsin; base; beneficiary; brain surgery; brain tissue; drug distribution; experience; image guided; image visualization; imaging modality; imaging platform; imaging system; improved; innovation; meetings; microwave ablation; neurosurgery; nonhuman primate; platform-independent; predictive modeling; prototype; public health relevance; research study; temporal measurement; tool

 DESCRIPTION (provided by applicant): Significance: Accurate targeting, guidance and monitoring of interventional therapy in the brain are critical for maximizing their effectiveness and safety during and following neurosurgical procedures. Magnetic resonance imaging (MRI) is a critical tool for planning and guiding neurosurgical procedures. In most cases, the MRI is obtained during a pre-operative session; however, either brain shift, errors in device guidance, or device malfunction can lead to poor outcomes. In particular for infusion-based therapies, the location of the infusion cannula in the brain, the difficulty of predicting how agents will distribte through the complex nature of brain tumors, and loss of the therapeutic agent through backflow or other mechanisms may significantly influence the therapeutic outcome. The inseRT MRI system provides a unique solution for providing real-time, interactive brain imaging for drug infusion procedures by providing a workflow environment that is intuitive for neurosurgeons. Phase I Progress: A successful model for iteratively developing, testing, accessing, and revising our platform based on rapid customer feedback has been implemented during Phase I. The platform was used to successfully guide and monitor gene delivery into 12 survival NHP models in a protocol demanding more precision than human protocols. Specific Aims of Phase II: This project will further develop the inseRT MRI system as a commercial product for image-guided drug infusion procedures. In Specific Aim 1, the inseRT MRI platform interface will add the remaining features our collaborators in Neurosurgery are requesting for a simplified, methodical workflow that is similar to the stereotactic procedures used in operating rooms today. The technology will be evaluated by neurosurgeons to demonstrate localization of targeting within 0.75 mm in gel phantoms and cadaver heads. In Specific Aim 2, predictive models of drug infusion distribution, used only in surgical planning today, will be integrated into the inseRT MRI system. Real-time, quantitative drug tracer information from the infusion in progress will be used to improve the algorithm's ability to demonstrate the most likely final drug distribution to the surgeon. This information can be used by the surgeon to alter the infusion to meet the treatment goals during surgery. Quantitative infusion concentration results will be tested against non-real-time measurement techniques. In Specific Aim 3, the inseRT MRI system with improved interface and predictive drug distribution modeling will be evaluated in animal models. These studies are designed as inputs for upcoming FDA IDE and 510k submissions.

 描述（由适用提供）：意义：精确的靶向，指导和监测大脑介入治疗对于在神经外科手术过程中和遵循神经外科手术过程中的有效性和安全性至关重要。磁共振成像（MRI）是计划和指导神经外科手术的关键工具。在大多数情况下，MRI是在术前会议中获得的；但是，无论是大脑的转移，设备引导中的错误还是设备故障都会导致结果不佳。特别是对于基于输注的疗法，输注套管在大脑中的位置，难以预测药物如何通过脑肿瘤的复杂性分布，以及通过回流或其他机制的治疗剂丧失可能会显着影响治疗结果。 Insert MRI系统通过提供神经外科医生直观的工作流环境，为药物输液程序提供实时的，交互式脑成像提供了独特的解决方案。第一阶段进度：基于快速客户反馈的迭代开发，测试，访问和修改我们的平台的成功模型。第二阶段的具体目的：该项目将进一步开发插入MRI系统作为图像引导的药物输液程序的商业产品。在特定的目标1中，插入MRI平台界面将添加我们的神经外科合作者的其余功能，要求提供简化的有条不紊的工作流程，该功能与当今手术室中使用的立体定向程序相似。该技术将通过神经外科医生进行评估，以证明在凝胶幻像和尸体头0.75 mm以内的靶向定位。在特定的目标2中，仅在当今手术计划中使用的药物输注分布的预测模型将整合到插入MRI中 系统。从进输注中的实时，定量的药物示踪剂信息将用于提高该算法证明向外科医生证明最终药物分布的能力。外科医生可以使用此信息来改变输注以满足手术期间的治疗目标。定量输注浓度结果将针对非实时时间测量技术进行测试。在特定的目标3中，将在动物模型中评估具有改进界面和预测药物分布模型的插入MRI系统。这些研究被设计为即将进行的FDA IDE和510K提交的输入。