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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Image-Guided Surgery

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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

Inclusion Criteria


- INCLUSION CRITERIA:

1. Patients must have primary or metastatic hepatic tumors scheduled for
trans-arterial chemo-embolization or bland embolization in interventional
radiology. A multidisciplinary 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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare safety, efficacy, and technical efficiency of navigation with 3D Roadmap vs. conventional image guidance during trans-arterial embolization procedures.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Nadine Abi-Jaoudeh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institutes of Health Clinical Center (CC)

Authority:

United States: Federal Government

Study ID:

130092

NCT ID:

NCT01818440

Start Date:

February 2013

Completion Date:

December 2014

Related Keywords:

  • Image-Guided Surgery
  • Surgical Navigation
  • Liver
  • Cancer
  • Image-guided Therapy

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892
Johns Hopkins UniversityBaltimore, Maryland  21205