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

This study has been completed.
Information provided by:
Aarhus University Hospital Identifier:
First received: October 26, 2009
Last updated: January 22, 2015
Last verified: October 2009

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.

Liver Cirrhosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Aarhus University Hospital:

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

Enrollment: 16
Study Start Date: October 2009
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT01002261     History of Changes
Other Study ID Numbers: gal-FDGal
R01DK074419 ( U.S. NIH Grant/Contract )
Study First Received: October 26, 2009
Last Updated: January 22, 2015

Keywords provided by Aarhus University Hospital:
Liver physiology
Liver pathophysiology

Additional relevant MeSH terms:
Liver Diseases
Liver Cirrhosis
Digestive System Diseases
Liver Extracts
Hematinics processed this record on September 20, 2017