Fluoroscopy or 3-D Roadmap Imaging Software for Liver Tumor Treatment

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

• INCLUSION CRITERIA:

• Patients must have primary or metastatic hepatic tumors scheduled for trans-arterial chemo-embolization or bland embolization in interventional radiology. A multi-disciplinary team including oncology, surgery, pathology and radiation oncology as well as interventional radiology will review each candidate and determine the eligibility for TACE or bland embolization and ineligibility for other interventions.
• Age >18 years
• They must be eligible for trans-arterial chemoembolization or bland embolization

Exclusion criteria

• Patients with an altered mental status precluding understanding or consenting for the procedure
• History of allergic reactions to iodine contrast, which cannot be controlled by premedication with antihistamines and steroids.
• Pregnant women are excluded from the study because ionizing radiation is teratogenic or abortifacient effects. Patients are excluded from pregnancy testing if they are above the childbearing age of 55 years old, or if they have documented history of infertility or acquired or congenital disorders incompatible with pregnancy or if the patient has had a hysterectomy or bilateral oophorectomy. Patients are also excluded from pregnancy testing if they are at least 50 years of age AND have not menstruated for at least 12 months OR have a documented Follicle Stimulating Hormone (FSH) level of greater than 40 mIU/mL.
• Patients with a total body weight exceeding 375 pounds since that is the weight limit of the angiography table.