Navigation tools for Image Guided Minimally invasive Therapies

图像引导微创治疗的导航工具

• 批准号: 10262633
• 负责人: Bradford Wood
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10262633
• 关键词: Ablation; Address; Adopted; Adoption; Anatomy; Angioplasty; Area; Atherosclerosis; Augmented Reality; Automation; Beds; Biopsy; Brain Aneurysms; Bronchoscopy; Caring; Catheters; Cellular Phone; Chemistry; Chemoembolization; Clinic; Clinical; Clinical Research; Clinical Treatment; Clinical Trials; Clip; Computer software; Data; Development; Device or Instrument Development; Devices; Diagnosis; Disease; Dose; Drug Combinations; Drug Delivery Systems; Drug Targeting; Electromagnetics; Endoscopes; Endoscopy; Engineering; European; Feedback; Fluoroscopy; Focused Ultrasound Therapy; Future; Goals; Grant; Home environment; Image; Imaging Device; In Vitro; Institutes; Intervention; Interventional radiology; Intramural Research Program; Investigation; Laboratory Research; Lasers; Legal patent; Liposomes; Liver; Localized Disease; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of prostate; Medical; Medical Device; Medicine; Metabolic; Methods; Miniaturization; Mission; 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Automation; Beds; Biopsy; Brain Aneurysms; Bronchoscopy; Caring; Catheters; Cellular Phone; Chemistry; Chemoembolization; Clinic; Clinical; Clinical Research; Clinical Treatment; Clinical Trials; Clip; Computer software; Data; Development; Device or Instrument Development; Devices; Diagnosis; Disease; Dose; Drug Combinations; Drug Delivery Systems; Drug Targeting; Electromagnetics; Endoscopes; Endoscopy; Engineering; European; Feedback; Fluoroscopy; Focused Ultrasound Therapy; Future; Goals; Grant; Home environment; Image; Imaging Device; In Vitro; Institutes; Intervention; Interventional radiology; Intramural Research Program; Investigation; Laboratory Research; Lasers; Legal patent; Liposomes; Liver; Localized Disease; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of prostate; Medical; Medical Device; Medicine; Metabolic; Methods; Miniaturization; Mission; Modality; Modeling; Molecular; Monitor; Morphology; Multimodal Imaging; Needles; Normal tissue morphology; Oncology; Operating Rooms; Operative Surgical Procedures; Optics; Paper; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Phase; Positioning Attribute; Positron-Emission Tomography; Pre-Clinical Model; Privatization; Procedures; Process; Property; Prostate; Prostate Ablation; Radiofrequency Interstitial Ablation; Rectum; Research; Research Project Grants; Resolution; Resources; Robotics; Rotation; Route; Sampling; Science; Solid Neoplasm; Standardization; Stents; System; Systemic disease; Techniques; Technology; Temperature; Testing; Therapeutic; Therapeutic Agents; Therapeutic Embolization; Therapeutic Intervention; Thermal Ablation Therapy; Time; Tissues; Toxic effect; Training Programs; Translating; Translational Research; Translations; Ultrasonography; United States National Institutes of Health; Uterine Fibroids; Vendor; Vision; Visualization; Work; anti-cancer therapeutic; anticancer treatment; base; bench to bedside; cancer therapy; checkpoint therapy; clinical center; clinically relevant; cone-beam computed tomography; cost effective; design; drug discovery; empowered; experience; falls; first-in-human; image guided; image guided intervention; image guided therapy; imaging modality; immune activation; improved; improved outcome; in vivo; instrumentation; interest; microwave electromagnetic radiation; minimally invasive; molecular targeted therapies; multi-component intervention; multidisciplinary; multimodality; new technology; novel; novel therapeutics; personalized therapeutic; pre-clinical; precision drugs; programs; prostate biopsy; prototype; radio frequency; radiological imaging; side effect; targeted treatment; temporal measurement; tool; tool development; treatment planning; tumor; tumor ablation; validation studies; vector

Summary: Research in the Interventional Radiology (IR) lab is motivated by the fact that image guidance and minimally invasive approaches have revolutionized the management of many common diseases. However, diagnosis and therapy remain distinctly separated from each other in both time and space. We believe that this gap between diagnosis and therapy can be narrowed by minimally invasive image guided therapies and with the application of novel guidance technologies and engineered vectors. All research efforts in the IR lab are developed with a clear translational route to the clinic and address areas of urgent clinical need. The IR labs research program is separated into three main areas: 1. electromagnetic (EM) and optical tracking and robotics, 2. drug + device combinations, 3. novel methods or devices to improve or augment ablative energy delivery (RFA, MWA, Laser, IRE, or HIFU). The diversity of these projects requires an interdisciplinary team and takes full advantage of the interdisciplinary resources found within the Clinical Center and the Intramural Research Program. We believe that combining the imaging tools, with pharmaceuticals and medical devices can make a significant contribution to the future treatment of localized and systemic diseases, such as cancer. Principal projects are: 1) Smart biopsy, 2) OR of the future 3) Drugs + devices. Smart biopsy relies upon precise electromagnetic or gyroscopic tracking to target tissue to correlate sample with imaging parameters. OR of the future is a broad translational project that integrates a variety of technologies for navigation, automation, and visualization of medical procedures. Sub-projects within the Drug + Device model include: 1) Temperature sensitive liposomes combined with radiofrequency ablation (RFA) or high intensity focused ultrasound (HIFU), 2) Radiofrequency ablation combined with immunotherapy / checkpoint inhibitor therapy, and 3) Image-able drug eluting beads (DEB) for trans-catheter arterial chemoembolization (TACE). The clinical treatment of solid tumors could be improved by controlling the pharmacologic properties of anticancer therapeutics to deliver a greater dose to the tumor; with conventional drugs, this dose is typically limited by toxic systemic side effects in normal tissues. Therefore, the efficacy of current anticancer treatments may be improved with advances in drug delivery technologies and paradigms, augmented or delivered via needle or catheter. The goal of drug delivery in the treatment of cancer is to increase the concentration of a therapeutic agent in the tumor while limiting systemic exposure and subsequent normal tissue toxicity. The combination of drug delivery technologies with image guided interventions represents a rich field with great translational potential and the ability to bridge the gap between diagnosis and therapy. Diagnosis and therapy remain distinctly separated from each other in time and space. The gap between diagnosis and therapy can be closed by minimally invasive image guided therapies. Real-time, intra-procedural tools will blend diagnosis and therapy into a dynamic, iterative process with improved outcomes. The redefining of surgical-like procedures is fueled by multi-modality imaging, navigation, visualization, robotics, and automated precision tools. These enabling technologies have not yet been fully applied to existing clinical problems, especially in minimally-invasive image guided therapies. This presents an opportunity to integrate these technologies into the clinical setting in a validated and cost-effective manner, and to study the impact prior to broader implementation. Image guidance and multimodality navigation has fueled a small revolution in procedural medicine, which presents unprecedented opportunity and challenge. Image guidance and minimally invasive approaches have revolutionized the management of many common diseases. The miniaturization of surgical interventions has seen the broad adoption of needle or catheter-based procedures such as tumor embolization, brain aneurysm coiling, aortic stent grafting, uterine fibroid embolization, atherosclerosis stenting and angioplasty, and cancer thermal ablation or immune activation with radiofrequency or other energies. As procedures are becoming less and less invasive, they are more and more targeted and guided by imaging and spatial information. The ability to navigate a medical device to a target based upon multiple windows or multiple modalities should have tremendous advantages in certain settings. The combination of functional and morphologic (metabolic and anatomic) information on the same coordinate system is empowering. With multiple public and private partners, we have developed a multimodality interventional radiology suite that uses a CT coordinate frame to co-register and co-localize different devices including pre-procedural images, intra-procedural ultrasound, CT, rotational fluoroscopy, endoscopy, robotics, electromagnetic tracking and therapeutic ultrasound, microwave, radiofrequency, etc. to allow the best combinations of techniques and guidance methods tailored to the particular patients needs. Combining imaging modalities can take advantage of each modality's strength. Real-time feedback and temporal resolution of ultrasound can be combined with the functional and metabolic data from PET and the spatial resolution of MR or CT, all on one seamless platform for treatment planning, targeting, procedural navigation, monitoring, and verification of treatment. The lab has continued the electromagnetic tracking clinical trial with well over 2000 patients. The lab also further studied Medical GPS for tumor ablation and treatment planning and for prostate biopsies using MRI information without requiring an MRI to be physically present. A novel use of the smartphone gyroscope as a handheld approach to needle positioning has led to an application soon to be available to the public. Smartphone guidance has been added to a clinical trial and an augmented reality platform should be placed into clinical use this year. Partners have achieved European CE Mark approval for use of a related system in patients. This work yielded numerous discoveries, papers, and commercialized products. Also as a result of this work, numerous vendors in the field have adopted similar multi-modality approaches. Early Phase of laser ablation of prostate cancer under MRI guidance was completed and Phase II-III work began fall 2017 and has continued since for using ultrasound alone to guide the prostate cancer ablation. Low tech, cost-effective methods for navigation continued, including laser guidance for needle based biopsy and ablation, and bronchoscopy navigation and laser ablation development. Advanced work is in process for focal prostate therapies (transperineal access and transperineal ultrasound to get the whole system out of the rectum. Composite treatment planning was refined with several derivative clinical softwares soon commercially available. Drug eluting immuno-beads as a tool for regional therapies was refined in preclinical chemistry and will be combined with image-able beads that show where the drug is being delivered in liver chemoembolization. Image-able drug eluting beads are being studied and refined in preclinical models and clinic, in order to develop drug dose planning software. Conductive catheters and endovascular devices and embolization devices were studied and prototyped, and NIH patents were issued on devices. Optical and EM needle endoscopy for biopsy will be tested under a UO1 grant and a clinical trial was approved in FY2020.

概括： 介入放射学（IR）实验室中的研究是由于图像指导和微创方法彻底改变了许多常见疾病的管理。 但是，在时间和空间中，诊断和治疗在彼此之间保持明显分离。 我们认为，诊断和治疗之间的这种差距可以通过微创图像指导疗法以及新颖的指导技术和工程载体的应用来缩小。 IR实验室中的所有研究工作均以通往诊所的清晰转换途径开发，并解决紧急临床需求的领域。 IR实验室研究计划分为三个主要领域：1。电磁（EM）和光学跟踪和机器人技术，2。药物 +设备组合，3。用于改善或增强消融能量传递的新方法或设备（RFA，MWA，MWA，Laser，Laser，IRE或HIFU）。 这些项目的多样性需要一个跨学科的团队，并充分利用了临床中心和壁内研究计划中发现的跨学科资源。我们认为，将成像工具与药品和医疗设备相结合可以为局部疾病（例如癌症）的未来治疗做出重大贡献。 主要项目是：1）智能活检，2）或未来3）药物 +设备。智能活检依靠精确的电磁或陀螺仪跟踪来靶向组织，以将样品与成像参数相关联。或未来是一个广泛的转化项目，该项目集成了各种用于导航，自动化和可视化医疗程序的技术。 Sub-projects within the Drug + Device model include: 1) Temperature sensitive liposomes combined with radiofrequency ablation (RFA) or high intensity focused ultrasound (HIFU), 2) Radiofrequency ablation combined with immunotherapy / checkpoint inhibitor therapy, and 3) Image-able drug eluting beads (DEB) for trans-catheter arterial chemoembolization (TACE).可以通过控制抗癌治疗剂的药理特性来改善实体瘤的临床治疗，从而为肿瘤提供更大的剂量。使用常规药物，该剂量通常受正常组织中有毒的全身副作用的限制。 因此，通过药物递送技术和范式的进步，通过针或导管扩大或传递的药物递送技术和范式的进步，当前抗癌治疗的疗效可以提高。癌症治疗药物的目的是增加肿瘤中治疗剂的浓度，同时限制全身暴露和随后的正常组织毒性。 药物输送技术与图像指导的干预措施的结合代表了一个丰富的领域，具有巨大的翻译潜力以及弥合诊断和治疗之间差距的能力。 诊断和治疗在时间和空间上仍然明显地彼此分离。诊断和治疗之间的差距可以通过微创图像指导疗法来缩小。实时的，手术内工具将诊断和治疗融合到动态的迭代过程中，并改善预后。多模式成像，导航，可视化，机器人技术和自动精度工具的重新定义类似于手术的过程。这些促成技术尚未完全应用于现有的临床问题，尤其是在微创图像指导疗法中。这为将这些技术集成到临床环境中的机会是有效且具有成本效益的方式，并在实施更广泛的实施之前研究了影响。 图像指导和多模式导航助长了程序医学的一场小革命，这给了前所未有的机会和挑战。图像指导和微创方法彻底改变了许多常见疾病的管理。手术干预的微型化已广泛采用了针头或基于导管的程序，例如肿瘤栓塞，脑动脉瘤卷曲，主动脉纤维支架移植，子宫肌瘤的栓塞，动脉粥样硬化施加和血管性置换术和血管性置换术以及癌症热平等或免疫效率或其他效果。 随着程序变得越来越少，它们越来越有针对性的成像和空间信息来指导和指导。根据多个窗口或多种模式将医疗设备导航到目标的能力在某些设置中具有巨大的优势。在同一坐标系上的功能和形态学（代谢和解剖学）信息的组合正在增强。 With multiple public and private partners, we have developed a multimodality interventional radiology suite that uses a CT coordinate frame to co-register and co-localize different devices including pre-procedural images, intra-procedural ultrasound, CT, rotational fluoroscopy, endoscopy, robotics, electromagnetic tracking and therapeutic ultrasound, microwave, radiofrequency, etc. to allow the best combinations of针对特定患者需求的技术和指导方法。结合成像方式可以利用每种方式的力量。超声的实时反馈和时间分辨率可以与PET的功能和代谢数据以及MR或CT的空间分辨率结合使用，所有这些都可以在一个无缝平台上用于治疗计划，靶向计划，程序性导航，监测和治疗验证。该实验室已继续进行电磁跟踪临床试验，其中超过2000名患者。该实验室还进一步研究了用于肿瘤消融和治疗计划以及使用MRI信息的前列腺活检的医学GP，而无需进行MRI进行物理存在。 将智能手机陀螺仪用作针线定位的手持式方法的新颖使用已导致申请即将向公众提供。智能手机的指导已添加到临床试验中，今年应将增强现实平台用于临床使用。合作伙伴已经获得了欧洲CE Mark的批准，用于使用患者的相关系统。 这项工作产生了许多发现，论文和商业化产品。同样，由于这项工作，该领域的许多供应商都采用了类似的多模式方法。在MRI指导下的前列腺癌的激光消融早期阶段已经完成，II-III阶段工作开始于2017年秋季，此后一直持续使用超声单独使用超声来指导前列腺癌消融。低技术，具有成本效益的导航方法继续进行，包括基于针头活检和消融的激光指南，以及支气管镜检查导航和激光消融开发。 Advanced work is in process for focal prostate therapies (transperineal access and transperineal ultrasound to get the whole system out of the rectum. Composite treatment planning was refined with several derivative clinical softwares soon commercially available. Drug eluting immuno-beads as a tool for regional therapies was refined in preclinical chemistry and will be combined with image-able beads that show where the drug is being delivered in liver在临床前和诊所中，正在研究和精致的象征性药物剂量剂量计划软件，并在临床上进行了原型，并研究了NIH的临床，在临床上进行了临床，对临床剂的临床和栓塞;