Status:
ACTIVE_NOT_RECRUITING
PET/CT Scans Using the Tracer 11C-Csar, a Bile Acid Analog, to Depict and Visualize Changes in the Hepatobiliary System in Patients With Primary Biliary Cholangitis Before and After Treatment.
Lead Sponsor:
University of Aarhus
Conditions:
Primary Biliary Cholangitis (PBC)
Cirrhosis
Eligibility:
All Genders
18+ years
Brief Summary
Purpose The primary purpose is to use an imaging diagnostic method to examine how the medication for primary biliary cholangitis (PBC) works. This will be studied using a radioactive tracer that behav...
Detailed Description
Cholestasis Cholestasis is defined as decreased bile flow from the liver to the duodenum, either due to hepatocellular functional defects or obstruction of the biliary tree (1). Bile acids are essenti...
Eligibility Criteria
Inclusion
- \- A clinical diagnosis of PBC as defined by guidelines (3).
- Age ≥ 18.
- For fertile female participants: A negative urinary pregnancy test performed on the day of the scan.
- Treatment-naïve patients:
- DiagnosisofPBCwithin\<1year
- NopriortreatmentforPBC(UDCA,bezafibrate)
- Non-responders to UDCA:
- Insufficient treatment response to UDCA defined by guidelines (ALP\>160U/I)
Exclusion
- \- 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 :
September 4 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06604923
Start Date
September 4 2024
End Date
June 1 2029
Last Update
September 20 2024
Active Locations (1)
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1
The Department of Hepatology and Gastroeneterology Aarhus University Hospital.
Aarhus, Denmark, 8210