Navigation Tools for Image Guided Minimally invasive Therapies

Clinical Center

Investigators

Linked publications & trials

Abstract

Research in Interventional Radiology (IR) navigations lab (within CIO) is motivated by image guidance and minimally invasive approaches which have revolutionized management of common diseases like cancer. However, diagnosis and therapy remain separated from each other in time and space. This gap between diagnosis and therapy can be narrowed by minimally invasive image guided therapies and with the application of novel navigation tools and guidance technologies. All research efforts in the IR lab in CIO are developed with a clear translational route to the clinic and address areas of urgent clinical need. The IR lab CIO navigation 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, PEF, Cryo, histotripsy 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. Combining 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 research biopsy, 2) OR of the future 3) Drugs + devices. Smart biopsy relies upon precise electromagnetic or gyroscopic tracking to target tissue to correlate tissue with imaging parameters from multiple sites for tumor heterogeneity. OR of the future is a broad translational project that integrates 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) Thermal ablation or TACE 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, catheter or energy (RFA or HIFU). 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 resulting 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 blend diagnosis and therapy into a dynamic, iterative process with improved outcomes. The minimization 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 a 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, 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, has advantages. The combination of functional and morphologic (metabolic and anatomic) information on the same cartesian XYZ coordinate system is empowering, to address questions such as how and where to apply AI models for IR cancer procedures (like biopsy) to decipher the temporal and spatial heterogeneities inherent to cancers (& the correlative biomarkers). With academic & private partners, a multimodality interventional radiology suite was developed 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 customize and characterize combinations of techniques and guidance methods personalized for each patient. Combining imaging modalities takes advantage of each modality's strengths. Real-time feedback and temporal resolution of ultrasound is 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 electromagnetic tracking clinical trial has thousands of patients longitudinally. Study of smart systems for tumor ablation and treatment planning and for prostate biopsies uses information, without requiring the imaging equipment (like MRI) to be physically present. Novel uses of smartphone and goggle applications for needle positioning have been deployed with cost effectiveness. Smartphone guidance has been added to a clinical trial and an augmented reality platform should be placed into clinical use. Goggle based Augmented Reality received FDA clearance. 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 prostate cancer focal ablation. Low tech, cost-effective methods for navigation include needle-based biopsy and ablation, and bronchoscopy navigation without expensive equipment. Focal prostate therapies via transurethral and transperineal access and transperineal ultrasound moved the whole system out of the rectum. Composite treatment planning was refined with several derivative clinical software available. Drug eluting immuno-beads as a tool for regional therapies were formulated and deployed in preclinical models for 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 for rapid artery occlusion were studied and prototyped. Optical and EM tracking needle endoscopy for biopsy was deployed in clinic under a UO1 grant and a clinical trial. Refinements are iterative and uniquely attainable within the one-of-a-kind "idea-to-bench-to-bedside-to market" multi-modality translational milieu of the NIH Intramural Research Program. Endobronchial devices and approaches to lung biopsy and ablation were developed as well. Team is key personnel on DOD and ARPA-H grants in ultrasound tomography & precision surgical interventions.