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Completed

NCT Number: NCT01879735

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Nuclear medicine and PET-center

Aarhus, Aarhus C, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with cholestatic disorders and healthy subjects

Exclusion criteria

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

Treatment and study plan

11C-CSar

Drug

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

Other names: 11C-cholylsarcosine

ICG

Drug

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

Other names: indocyanine green

Primary outcomes

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

    Time frame: All measurements are performed in one day.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 18, 2013
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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