Rebecca Fahrig
Impact of C-arm CT in patients with HCC undergoing TACE: Optimal Imaging Guidance
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedIntervention(s):
- Device: C-arm CT in imaging guidance of TACE
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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.
Key Exclusion Criteria:
Subjects under the age of 18
Pregnant women
Additional Study Details
Official Title:
Impact of C-arm CT in patients with hepatocellular carcinoma (HCC) undergoing transhepatic arterial chemoembolization (TACE): Optimal Imaging GuidanceAnticipated start date:
4/13/2009Lead Sponsor:
Stanford UniversityCollaborator(s):
- Siemens Healthcare Sector
Investigator(s):
Study Type:
InterventionalPurpose:
DiagnosticAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- 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.
Secondary Outcomes:
- To determine if using CACT also reduces total procedure time.
Total Number to be Enrolled:
144Total Number to be Enrolled at Stanford:
144More Information
Secondary ID(s):
- HEP0020
- NCT00926536
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/12/2011PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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