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.|
|ClinicalTrials.gov Identifier: NCT00926536|
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : April 4, 2016
Last Update Posted : April 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Device: C-arm CT + DSA as needed Device: DSA only||Not Applicable|
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:
- Sensitivity and specificity to diagnose additional tumors and its impact on transplantation criteria.
- The ability to decrease procedural time by aiding navigation through complex arterial anatomy.
- 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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- 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)
- 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)
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 ClinicalTrials.gov identifier (NCT number): NCT00926536
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Dr. Rebecca Fahrig||Stanford University|
|Principal Investigator:||Nishita N. Kothary||Stanford University|