Early Phase 1
N=8
The Role of Gadoxetate (Eovist) Enhanced CT in Evaluating Cholangiocarcinoma
Cholangiocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01673802 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT — 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- CT scan (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT |
5 | — |
Summary
The purpose of this project is to evaluate the role of gadoxetate (Eovist®) enhanced dual-energy CT in better evaluating perihilar cholangiocarcinoma. This pilot project aims to address a long-term pitfall in the imaging of cholangiocarcinomas, by providing higher resolution delineation of these often infiltrative tumors on single-source, Dual-Energy Spectral Multi Detector CT (MDCT), capitalizing on improved spatial resolution achievable with MDCT compared to MRI and at the same time producing a non-invasive CT cholangiogram to aid in accurate diagnosis and treatment planning of cholangiocarcinoma, particularly, the hilar variety.
Eligibility Criteria
Inclusion Criteria
- Subjects will be adult (age 19 or older) with suspected cholangiocarcinoma of the liver.
- Subject must be able to provide a written informed consent.
- Subject will be scheduled for gadoxetate contrast enhanced MRI scan of the liver (obtained as part of usual clinical practice).
Exclusion Criteria
- Standard MRI safety screening criteria will be employed, and subject will be excluded if any contraindications to undergo MRI are met.
- Subjects with metallic biliary stents or multiple peripancreatic surgical clips on abdominal MDCT will be excluded.
- Subjects on hemodialysis or with glomerular filtration rate (GFR) less than 30 will be excluded.
- Subjects will not be excluded on the basis of gender, race, ethnicity, or religion.
- Subject may not be pregnant or lactating.
Data sourced from ClinicalTrials.gov (NCT01673802). 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.