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Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01002261
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : January 26, 2015
Information provided by:

Study Description
Brief Summary:

The elimination of the carbohydrate galactose is used in daily clinical work with liver patients as a quantitative measure of metabolic liver function, as the liver test "The Galactose Elimination Capacity", GEC. We are working to develop a PET/CT scanning procedure for providing 3D images of the hepatic galactose elimination and measurement of regional values. This may be used for example for planning resection or stereotactic radiotherapy of a patient with malignant tumor in the liver. Will the patient be able to tolerate removal of the necessary part of the liver? We will include 10 patients with liver cirrhosis and 6 healthy human subjects. Direct measurements of the hepatic galactose elimination (successive constant iv infusions of galactose in increasing doses with measurements of blood concentrations of galactose in blood from an artery and a liver vein, and measurements of liver blood flow by indocyanine green, Ficks principle) are compared with PET/CT measurements after iv injection of a 18F-labelled galactose analog, FDGal.

Based on previous studies in pigs, we perform detailed calculations of the hepatic galactose elimination kinetics by the two methods, including estimation of a factor ("lumped constant") for recalculating PET/CT data to data for natural galactose.

Besides possible practical clinical importance, the project elucidates basic problems concerning liver metabolism using PET.

Condition or disease
Liver Cirrhosis

Study Design

Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects
Study Start Date : October 2009
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Liver cirrhosis / healthy subjects
10 patients with liver cirrhosis and 10 sex and age-matched healthy subjects
Liver cirrhosis and healthy subjects
Patients with liver cirrhosis and healthy subjects

Outcome Measures

Primary Outcome Measures :
  1. Lumped constant for recalculation of PET/CT data for FDGalactose to data for natural galactose [ Time Frame: May 2011 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients are out-patients recruited from Department of Hepatology, Aarhus University Hospital Healthy subjects are recruited via add in a local newspaper

Inclusion Criteria:

  • liver cirrhosis

Exclusion Criteria:

  • hepatic encephalopathy
  • pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002261

Aarhus University Hospital, PET Centre
Aarhus, Denmark, DK 8000
Sponsors and Collaborators
Aarhus University Hospital
Study Director: John Westensee, Mr Research Support Office, Aarhus University Hospital
More Information

Additional Information:
Responsible Party: Susanne Keiding (PI), Aarhus University Hospital, 8000 Aarhus C, Denmark
ClinicalTrials.gov Identifier: NCT01002261     History of Changes
Other Study ID Numbers: gal-FDGal
R01DK074419 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: October 2009

Keywords provided by Aarhus University Hospital:
Liver physiology
Liver pathophysiology

Additional relevant MeSH terms:
Liver Diseases
Liver Cirrhosis
Digestive System Diseases
Liver Extracts