Conditions: Cholestasis Primary Sclerosing Cholangitis Primary Biliary Cirrhosis
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 22
Healthy volunteers: yes

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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: 11C-CSar intervention 2: ICG
Intervention descriptions: intervention 1: PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids. intervention 2: Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar.

Protocol document: