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

University of Aarhus

Status and phase: Completed; Phase 1

Conditions: Primary Sclerosing Cholangitis; Cholestasis; Primary Biliary Cirrhosis

Treatments: Drug: 11C-CSar; Drug: ICG

Study type: Interventional

Funder types: Other

Identifiers

NCT01879735

C-CSar humane 244

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with cholestatic disorders and healthy subjects

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

ICG's effect on 11C-CSar transport

Experimental group

Description:

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.

Treatment:

Drug: ICG

Drug: 11C-CSar

Infusion method

Experimental group

Description:

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.

Treatment:

Drug: ICG

Drug: 11C-CSar