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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926536
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Siemens Healthcare Diagnostics Inc
Information provided by (Responsible Party):
Nishita Kothary, Stanford University

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Device: C-arm CT + DSA as needed Device: DSA only Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Dose Area Product (DAP) [ Time Frame: Duration of a TACE procedure, an average of 2 hours ]
    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)

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00926536

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

Responsible Party: Nishita Kothary, Assistant Professor, Stanford University Identifier: NCT00926536     History of Changes
Other Study ID Numbers: IRB-15849
SU-05122009-2518 ( Other Identifier: Stanford University )
HEP0020 ( Other Identifier: OnCore )
First Posted: June 23, 2009    Key Record Dates
Results First Posted: April 4, 2016
Last Update Posted: April 4, 2016
Last Verified: March 2016

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