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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:
Stanford University
ClinicalTrials.gov Identifier:
NCT00926536
First received: June 22, 2009
Last updated: May 19, 2011
Last verified: May 2011
History of Changes
  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 F and DSA only, or TACE using F, DSA, and CACT. 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 in imaging guidance of TACE

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

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To determine if the increased radiation dose from CACT is outweighed by the increased information it provides, leading to lower total radiation dose required for catheter positioning. [ Time Frame: unknown ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine if using CACT also reduces total procedure time. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: C-arm CT in imaging guidance of TACE
    Standard of care
    Other Name: x-ray image intensifier
  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
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

No publications provided

Responsible Party: Dr. Rebecca Fahrig, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00926536     History of Changes
Other Study ID Numbers: SU-05122009-2518, HEP0020
Study First Received: June 22, 2009
Last Updated: May 19, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013