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

NCT ID: NCT00926536

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-03-31

Brief Summary

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.

Detailed 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

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

C-arm CT + DSA as needed'

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.

Group Type: EXPERIMENTAL

C-arm CT + DSA as needed

Intervention Type: DEVICE

C-arm CT images obtained and supplemented with DSA if needed

DSA only

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.

Group Type: ACTIVE_COMPARATOR

DSA only

Intervention Type: DEVICE

DSA imaging only

Interventions

C-arm CT + DSA as needed

C-arm CT images obtained and supplemented with DSA if needed

Intervention Type: DEVICE

DSA only

DSA imaging only

Intervention Type: DEVICE

Other Intervention Names

x-ray image intensifier; C-arm CT; Standard of care

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siemens Healthcare Diagnostics Inc

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Nishita Kothary

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Rebecca Fahrig

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Nishita N. Kothary

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-05122009-2518

Identifier Type: OTHER

Identifier Source: secondary_id

HEP0020

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-15849

Identifier Type: -

Identifier Source: org_study_id