N/A
N=87
Impact of C-arm CT in Patients With HCC Undergoing TACE: Optimal Imaging Guidance
Carcinoma, Hepatocellular
Bottom Line
View on ClinicalTrials.gov: NCT00926536 ↗Enrolled (actual)
87
Serious AEs
1.2%
Results posted
Apr 2016
Primary outcome: Primary: Dose Area Product (DAP) — 184.2; 137.4 Gy.cm2 — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- C-arm CT + DSA as needed (Device); DSA only (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Area Product (DAP) |
184.2; 137.4 | <.001 sig |
| PRIMARY Cumulative Dose (CD), a Measure of Radiation Dose |
626.4; 784.7 | 0.017 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00926536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.