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

This study has been completed.
Sponsor:
Collaborator:
Siemens Healthcare Diagnostics Inc
Information provided by (Responsible Party):
Nishita Kothary, Stanford University
ClinicalTrials.gov Identifier:
NCT00926536
First received: June 22, 2009
Last updated: March 10, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Carcinoma, Hepatocellular
Device: C-arm CT + DSA as needed
Device: DSA only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Impact of C-arm CT in Patients With Hepatocellular Carcinoma (HCC) Undergoing Transhepatic Arterial Chemoembolization (TACE): Optimal Imaging Guidance

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Dose Area Product (DAP) [ Time Frame: Duration of a TACE procedure, an average of 2 hours ] [ Designated as safety issue: Yes ]
    Dose area product (DAP) is a measure of the entire amount of energy (radiation dose) delivered to the patient by the beam (indicator of stochastic dose)

  • Cumulative Dose (CD), a Measure of Radiation Dose [ Time Frame: Duration of a TACE procedure, an average of 2 hours ] [ Designated as safety issue: Yes ]
    CD - a measurement of total radiation to the skin (measure of a deterministic dose)


Enrollment: 84
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: C-arm CT + DSA as needed
C-arm CT images obtained and supplemented with DSA if needed
Other Names:
  • x-ray image intensifier
  • C-arm CT
Active Comparator: 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.
Device: DSA only
DSA imaging only
Other Name: Standard of care

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926536

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Siemens Healthcare Diagnostics Inc
Investigators
Principal Investigator: Dr. Rebecca Fahrig Stanford University
Principal Investigator: Nishita N. Kothary Stanford University
  More Information

Responsible Party: Nishita Kothary, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00926536     History of Changes
Other Study ID Numbers: IRB-15849  SU-05122009-2518  HEP0020 
Study First Received: June 22, 2009
Results First Received: December 4, 2014
Last Updated: March 10, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on April 27, 2016