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

NCT01879735 | Completed Phase 1 Results

• 1 other identifier: C-CSar humane 244
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholestasis; Primary Sclerosing Cholangitis; Primary Biliary Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar

  All measurements are performed in one day.

Study Arms (2)

ICG's effect on 11C-CSar transport

EXPERIMENTAL

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; Drug: ICG

Infusion method

EXPERIMENTAL

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; Drug: ICG

Interventions

11C-CSar DRUG

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

Also known as: 11C-cholylsarcosine

ICG's effect on 11C-CSar transport; Infusion method

ICG DRUG

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

Also known as: indocyanine green

ICG's effect on 11C-CSar transport; Infusion method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cholestatic disorders and healthy subjects

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Nuclear medicine and PET-center

Aarhus, Aarhus C, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 28249726 DERIVED

MeSH Terms

Conditions

Cholestasis; Cholangitis, Sclerosing; Liver Cirrhosis, Biliary

Interventions

cholylsarcosine; Indocyanine Green

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholangitis; Cholestasis, Intrahepatic; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Susanne Keiding M.D., Associate professor, D.Sc.
• Organization: Dept. of Nuclear Medicine & PET-center, Dept. of Hepatology and Gastroenterolgy. Aarhus University Hospital

susanne@pet.auh.dk

+45 7846 3031

Study Officials

• Susanne Keiding, M.D. D.Sc.

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 18, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 23, 2015
• Results First Posted: February 23, 2015

Record last verified: 2014-07

Locations

DK (1)