Prospective Randomized Trial Comparing Navigation With 3D Roadmap vs. Conventional Angiography During Transarterial Embolization

Background: This is a phase II prospective randomized trial comparing novel tumor segmentation and navigation with 3D roadmap vs. conventional imaging with angiography during trans-arterial embolization procedures. Cone beam CT (CBCT) obtains CT-like images in the angiography suite during trans-arterial chemoembolization procedures and liver chemo-perfusion (PHP). In addition, 2D liver perfusion metrics can be calculated from angiography images. 3D Roadmap is a navigation tool/ software that utilize the data from the CBCT overlaid on live fluoroscopy to display a segmented tumor, delineate its vascular supply and to navigate catheters to the target vessels. Moreover, with 3D Roadmap, CBCT can be fused to prior CT or MRI for improved target visualization. The 3D Roadmap software received 510 (k) clearance on February 19, 2004. Our CRADA partner, Philips Healthcare, also submitted and received a separate 510 (k) clearance on January 30, 2015 for the software s vessel segmentation functionality and is under the trade name Emboguide. 3D Roadmap/ Emboguide software is intended to be used in combination with the AlluraClarity X-ray system. Primary Objective: To compare safety, and technical efficiency of navigation with 3D Roadmap vs. conventional image guidance during trans-arterial embolization procedures. Eligibility: Subjects are eligible if: They are more than 18 years of age They have primary or metastatic hepatic tumors scheduled for trans-arterial chemo- embolization or bland embolization in interventional radiology They are eligible for trans-arterial chemoembolization or bland embolization Subjects are excluded if they have: An altered mental status precluding understanding or consenting for the procedure Contra-indications to trans-arterial embolization A gross body weight exceeding 375 pounds (upper limit of angio table) A pregnancy A severe allergic reaction to iodine contrast which cannot be controlled by premedication with antihistamines and steroids Design: Number of Participants: 30 Recruitment Time Frame: 2 years Number of sites: 1 Type of Study: prospective randomized clinical trial