Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01002261|
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : January 26, 2015
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|
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|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|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
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
- Lumped constant for recalculation of PET/CT data for FDGalactose to data for natural galactose [ Time Frame: May 2011 ]
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|
|Study Director:||John Westensee, Mr||Research Support Office, Aarhus University Hospital|