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

Primary Sclerosing Cholangitis Clinical Trial

Official title:

Hepatic Transport of Conjugated Bile Acids in Humans Quantified by 11C-cholylsarcosine PET/CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879735
• Other study ID #: C-CSar humane 244
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2013
• Last updated: February 4, 2015
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: July 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with cholestatic disorders and healthy subjects

Exclusion Criteria:

• Body weight above 110 kg (catheterization problematic).

• Diabetes

• Pregnant or breast feeding women.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Cholestasis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis
• Primary Sclerosing Cholangitis

Intervention

Drug:
• 11C-CSar
PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids.
• ICG
Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar.

Locations

Country	Name	City	State
Denmark	Department of Nuclear medicine and PET-center	Aarhus	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar		All measurements are performed in one day.	No