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

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ClinicalTrials.gov Identifier: NCT01879735
Recruitment Status : Completed
First Posted : June 18, 2013
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cholestasis Primary Sclerosing Cholangitis Primary Biliary Cirrhosis Drug: 11C-CSar Drug: ICG Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Hepatic Transport of Conjugated Bile Acids in Humans Quantified by 11C-cholylsarcosine PET/CT
Study Start Date : June 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014


Arm Intervention/treatment
Experimental: 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.
Drug: 11C-CSar
PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids.
Other Name: 11C-cholylsarcosine

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

Experimental: 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.
Drug: 11C-CSar
PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids.
Other Name: 11C-cholylsarcosine

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




Primary Outcome Measures :
  1. Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar [ Time Frame: All measurements are performed in one day. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879735


Locations
Denmark
Department of Nuclear medicine and PET-center
Aarhus, Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Susanne Keiding, M.D. D.Sc. Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01879735     History of Changes
Other Study ID Numbers: C-CSar humane 244
First Posted: June 18, 2013    Key Record Dates
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015
Last Verified: July 2014

Additional relevant MeSH terms:
Cholangitis
Cholestasis
Cholangitis, Sclerosing
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Liver Diseases
Liver Cirrhosis
Bile Acids and Salts
Gastrointestinal Agents