Trial Information

Prospective Randomized Multicenter 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 that utilizes 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.

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: 2

- Type of Study: prospective randomized clinical trial