Impact of C-arm CT in Patients With HCC Undergoing TACE: Optimal Imaging Guidance

Stanford University

Status: Completed

Conditions: Carcinoma, Hepatocellular

Treatments: Device: C-arm CT + DSA as needed; Device: DSA only

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00926536

HEP0020 (Other Identifier)

SU-05122009-2518 (Other Identifier)

IRB-15849

Details and patient eligibility

About

Patients will be enrolled based on presence of HCC and eligibility for TACE. They will be randomized to one of two arms for imaging navigation to the optimal catheter location for chemotherapy injection to treat the first (possibly sole) tumor target. The two arms will be: TACE using C-arm CT supplemented by DSA or DSA only (only DSA images will be used for navigation and tumor vessel tracking). Navigation to subsequent treatment targets in all patients will be done with fluoroscopy, CACT, and DSA, as is standard of care at Stanford University Medical Center, and is not part of the study. Vascular complexity, which affects navigation difficulty and thus the need for imaging, will be assessed separately for use in data analysis by two radiologists on a four-point scale.

Full description

We hope to learn more about the utility of C-arm CT in patients undergoing TACE for HCC. Data will be evaluated with regards to:

1. Sensitivity and specificity to diagnose additional tumors and its impact on transplantation criteria.
2. The ability to decrease procedural time by aiding navigation through complex arterial anatomy.
3. Impact on radiation dose. Although the patient would receive the radiation during C-arm CT, overall the number of DSA angiograms and fluroscopy may decrease, potentially negating any effect of the additional dose from C-arm CT

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients must be affected by HCC

Patients must be 18 years old or older

Patients must have received an abdominal CT, PET/CT scan or MRI, completed prior to the TACE procedure.

Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

Subjects under the age of 18

Pregnant women

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

C-arm CT + DSA as needed'

Experimental group

Description:

In the group of subjects randomized in this group, the image guidance component of the procedure will be conducted by the acquisition of 3D CT-like images during a trans-hepatic arterial injection of iodinated contrast agent for road mapping the tumor feeding vessels and supplemented by DSA as needed by the operating physician as imaging guidance for planning tumor(s) treatment approach.

Treatment:

Device: C-arm CT + DSA as needed

DSA only

Active Comparator group

Description:

In the group of subjects randomized in this group, present standard of care, i.e DSA imaging only will be used by the operating physician to map out the tumor vessels and used for treatment approach. Additional 3D CT-like images will be obtained, but only used if the operator cannot perform adequate planning using DSA alone.

Treatment:

Device: DSA only