Phase 1
N=22
Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT
Cholestasis · Primary Sclerosing Cholangitis · Primary Biliary Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT01879735 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar — 100; 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 11C-CSar (Drug); ICG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Aarhus
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar |
100; 100 | — |
Summary
We wish to develop a protocol for PET/CT examination of humans using the bile acid tracer 11C-cholylsarcosine. This is done by a series of PET/CT examinations of healthy humans and patients with cholestatic disorders.
Eligibility Criteria
Inclusion Criteria
- Patients with cholestatic disorders and healthy subjects
Exclusion Criteria
- Body weight above 110 kg (catheterization problematic).
- Diabetes
- Pregnant or breast feeding women.
Data sourced from ClinicalTrials.gov (NCT01879735). 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.