NCT01879735

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

Hepatic Transport of Conjugated Bile Acids in Humans Quantified by 11C-cholylsarcosine PET/CT

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cholestasis
• Primary Sclerosing Cholangitis
• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	11C-CSar	PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids.
DRUG	ICG	Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar.

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-06-18
• Last updated: 2015-02-23
• Results posted: 2015-02-23

Locations

1 site across 1 country: Denmark