Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT

Phase 1

Completed

• Conditions: Cholestasis; Primary Biliary Cirrhosis; Primary Sclerosing Cholangitis
• Interventions: Drug: 11C-CSar; Drug: ICG

• Registration Number: NCT01879735
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

The purpose of the study is the development of PET/CT protocols using 11C-CSar for human use. PET/CT methods developed in the pig studies are translated to studies in healthy humans and patients with cholestatic disorders. Dynamic PET/CT scans of the liver and biliary system are combined with measurements of tracer concentrations in a radial artery and a liver vein and measurements of hepatic blood flow by intravenous infusion of indocyanine green (ICG)/Ficks principle. Kinetic parameters from PET/CT measurements and invasive measurements are compared for validation of the PET estimated parameters and refinement of the PET modeling, if required.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-18
• Status Verified: 2014-07
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-01-19
• Results First Submitted QC: 2015-02-04
• Last Update Submitted: 2015-02-04
• Results First Posted: 2015-02-23
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patients with cholestatic disorders and healthy subjects

Exclusion Criteria

• Body weight above 110 kg (catheterization problematic).
• Diabetes
• Pregnant or breast feeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infusion method	ICG	Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. If ICG does not affect the kinetics of 11C-CSar it will be used during these experiments to calculate hepatic blood flow.
ICG's effect on 11C-CSar transport	ICG	Examine the effect of ICG on the kinetics of the hepatic transport of 11C-CSar. If no effect is seen on the kinetics, ICG will be used during the "infusion method" experiments.
Infusion method	11C-CSar	Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. If ICG does not affect the kinetics of 11C-CSar it will be used during these experiments to calculate hepatic blood flow.
ICG's effect on 11C-CSar transport	11C-CSar	Examine the effect of ICG on the kinetics of the hepatic transport of 11C-CSar. If no effect is seen on the kinetics, ICG will be used during the "infusion method" experiments.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar	All measurements are performed in one day.

Trial Locations

Locations (1)

Department of Nuclear medicine and PET-center; 🇩🇰 Aarhus, Aarhus C, Denmark