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:

1. 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.

2. Age >18 years

3. They must be eligible for trans-arterial chemoembolization or bland embolization

EXCLUSION CRITERIA:

1. Patients with an altered mental status precluding understanding or consenting for the
procedure

2. History of allergic reactions to iodine contrast, which cannot be controlled by
premedication with antihistamines and steroids.

3. 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.

4. Patients with a total body weight exceeding 375 pounds since that is the weight limit
of the angiography table.