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

NCT ID: NCT01879735

Last Updated: 2015-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-09-30

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.

Conditions

Cholestasis; Primary Sclerosing Cholangitis; Primary Biliary Cirrhosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

ICG's effect on 11C-CSar transport

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.

Group Type: EXPERIMENTAL

11C-CSar

Intervention Type: DRUG

PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids.

ICG

Intervention Type: DRUG

Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar.

Infusion method

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.

Group Type: EXPERIMENTAL

11C-CSar

Intervention Type: DRUG

PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids.

ICG

Intervention Type: DRUG

Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar.

Interventions

11C-CSar

PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids.

Intervention Type: DRUG

ICG

Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar.

Intervention Type: DRUG

Other Intervention Names

11C-cholylsarcosine; indocyanine green

Eligibility Criteria

Inclusion Criteria

• Patients with cholestatic disorders and healthy subjects

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susanne Keiding, M.D. D.Sc.

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Department of Nuclear medicine and PET-center

Aarhus, Aarhus C, Denmark

Countries

Denmark

References

Orntoft NW, Munk OL, Frisch K, Ott P, Keiding S, Sorensen M. Hepatobiliary transport kinetics of the conjugated bile acid tracer 11C-CSar quantified in healthy humans and patients by positron emission tomography. J Hepatol. 2017 Aug;67(2):321-327. doi: 10.1016/j.jhep.2017.02.023. Epub 2017 Feb 27.

Reference Type: DERIVED

PMID: 28249726 (View on PubMed)

Other Identifiers

C-CSar humane 244

Identifier Type: -

Identifier Source: org_study_id