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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01879735
First Posted: June 18, 2013
Last Update Posted: February 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Aarhus
  Purpose
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 Intervention Phase
Cholestasis Primary Sclerosing Cholangitis Primary Biliary Cirrhosis Drug: 11C-CSar Drug: ICG Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

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

Enrollment: 22
Study Start Date: June 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01879735     History of Changes
Other Study ID Numbers: C-CSar humane 244
First Submitted: June 11, 2013
First Posted: June 18, 2013
Results First Submitted: January 19, 2015
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