Impact of C-arm CT in Patients With HCC Undergoing TACE: Optimal Imaging Guidance
| Status: | Completed |
|---|---|
| Conditions: | Liver Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2009 |
| End Date: | March 2010 |
Impact of C-arm CT in Patients With Hepatocellular Carcinoma (HCC) Undergoing Transhepatic Arterial Chemoembolization (TACE): Optimal Imaging Guidance
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.
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.
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
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
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
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