Status:
ENROLLING_BY_INVITATION
PET/CT Scans Using the Tracer 11C-Csar, a Bile Acid Analog, to Depict and Visualize Cholestatic Disorders in Patients with Genetic Liver Disorders and Healthy Individuals
Lead Sponsor:
University of Aarhus
Conditions:
Cholestasis
Genetic Liver Disorder
Eligibility:
All Genders
18+ years
Brief Summary
Purpose The primary goal is to study liver diseases with defects in bile excretion. Investigators aim to do this using a radioactive tracer that mimics human bile and can be visualized with a PET/CT s...
Detailed Description
Background Cholestasis is defined as a decreased flow of bile from the liver to the duodenum, either due to reduced excretion from the liver, defects in the enterohepatic circulation or blockage of t...
Eligibility Criteria
Inclusion
- Criteria for inclusion of healthy individuals
- No prior or current history of liver diseases
- No medication that interferes with the hepatobiliary system
- Age above 18
- A signed consent must be present on the day of the 11-CSAR PET/CT scan.
- A negative pregnancy test performed on the day of the scan.
Exclusion
- Prior cholecystectomy
- Pregnancy
- Assessed ineligibility by a medical doctor based on blood parameters measured at inclusion if these are abnormal.
- Claustrophobia or the inability to remain still during a 45-minute scan.
- Criteria for inclusion of patients with cholestasis
- Cholestasis at the time of inclusion, measured by elevated AP, bilirubin, or both.
- Ultrasound sonography which ruled out mechanical obstruction.
- Age above 18
- A signed consent must be present on the day of the 11C-CSAR PET/CT scan.
- A negative pregnancy test performed on the day of the scan. Criteria for exclusion of patients with cholestasis
- Pregnancy
- Claustrophobia or the inability to remain still during a 45-minute scan.
- Coagulation deficiency that does not allow hepatic vein catheter (relative).
Key Trial Info
Start Date :
August 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06610695
Start Date
August 15 2024
End Date
April 1 2029
Last Update
September 24 2024
Active Locations (1)
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1
The Department of Hepatology and Gastroeneterology Aarhus University Hospital.
Aarhus, Denmark, 8200