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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01879735
First received: June 11, 2013
Last updated: July 8, 2014
Last verified: July 2014
  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 health humans and patients with cholestatic disorders.


Condition Intervention Phase
Cholestatic Liver Disorders
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: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Quantifying the rate constants (uptake from blood, excretion to bile and excretion back into blood) for the hepatic transport of 11C-CSar [ Time Frame: Participants will be followed for the duration the of examination, a total of 8.5 hours. Data is analyzed immediately after investigation and collectedly after inclusion of the last subject. ] [ Designated as safety issue: No ]
    We will assess if 11C-CSar PET/CT studies can quantify the rate constants for the transport of 11C-CSar from blood-to-hepatocytes and from hepatocytes-to-bile - as expected from the pig studies (Frisch et al 2011) and in on-going pig studies


Secondary Outcome Measures:
  • Evaluating if ICG effect the rate constants (uptake from blood, excretion into bile and excretion back into blood) for the hepatic transport of 11C-CSar [ Time Frame: Participants will be followed for the duration of the examination, a total of 8.5 hours. Data is analyzed immediately after investigation and collectedly after inclusion of the last subject. ] [ Designated as safety issue: No ]
    Evaluate if simultaneous infusion of ICG affects the hepatic transport of 11C-CSar.


Estimated Enrollment: 22
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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 rate constants for the hepatic transport of 11C-CSar
Drug: 11C-CSar
Bile acid tracer 11C-cholylsarcosine and PET/CT scanning used to evaluate the rate constants for the transport of bile acids between blood and liver cells and from liver cells and into the bile canaliculi
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: bolus vs. constant infusion
Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning.
Drug: 11C-CSar
Bile acid tracer 11C-cholylsarcosine and PET/CT scanning used to evaluate the rate constants for the transport of bile acids between blood and liver cells and from liver cells and into the bile canaliculi
Other Name: 11C-cholylsarcosine

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. Based on these invasive studies, a protocol without liver vein catheterization is develop for subsequent clinical applications.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879735

Contacts
Contact: Susanne Keiding, M.D. DMSc +45 78463031 susanne@pet.dk

Locations
Denmark
Department of Nuclear medicine and PET-center Recruiting
Aarhus, Aarhus C, Denmark, 8000
Contact: Susanne Keiding, MD DMSc    +45 78463031    susanne@pet.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Susanne Keiding, M.D. DMSc Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01879735     History of Changes
Other Study ID Numbers: C-CSar humane 244
Study First Received: June 11, 2013
Last Updated: July 8, 2014
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Liver Cirrhosis, Biliary
Cholangitis
Cholangitis, Sclerosing
Liver Cirrhosis
Fibrosis
Liver Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Pathologic Processes
Bile Acids and Salts
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014