Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT
Primary Purpose
Cholestasis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
11C-CSar
ICG
Sponsored by
About this trial
This is an interventional basic science trial for Cholestasis
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.
Sites / Locations
- Department of Nuclear medicine and PET-center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ICG's effect on 11C-CSar transport
Infusion method
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01879735
Brief Title
Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT
Official Title
Hepatic Transport of Conjugated Bile Acids in Humans Quantified by 11C-cholylsarcosine PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICG's effect on 11C-CSar transport
Arm Type
Experimental
Arm Description
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.
Arm Title
Infusion method
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
11C-CSar
Other Intervention Name(s)
11C-cholylsarcosine
Intervention Description
PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids.
Intervention Type
Drug
Intervention Name(s)
ICG
Other Intervention Name(s)
indocyanine green
Intervention Description
Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar.
Primary Outcome Measure Information:
Title
Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar
Time Frame
All measurements are performed in one day.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Keiding, M.D. D.Sc.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nuclear medicine and PET-center
City
Aarhus
State/Province
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
28249726
Citation
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.
Results Reference
derived
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Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT
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