Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects
Recruitment status was Not yet recruiting
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.
|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|
- Lumped constant for recalculation of PET/CT data for FDGalactose to data for natural galactose [ Time Frame: May 2011 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||May 2011|
|Estimated Primary Completion Date:||October 2010 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002261
|Contact: Susanne Keiding, Prof, MD||+45 89493031 ext firstname.lastname@example.org|
|Contact: Michael Sørensen, PhD, MD||+45 89493033 ext email@example.com|
|Aarhus University Hospital, PET Centre||Not yet recruiting|
|Aarhus, Denmark, DK 8000|
|Contact: John Westensee, Dr. +45 89492379|
|Principal Investigator: Susanne Keiding, Prof., MD|
|Study Director:||John Westensee, Mr||Research Support Office, Aarhus University Hospital|