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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Aarhus University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01002261
First received: October 26, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 26, 2009
October 26, 2009
October 2009
October 2010   (final data collection date for primary outcome measure)
Lumped constant for recalculation of PET/CT data for FDGalactose to data for natural galactose [ Time Frame: May 2011 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects
Determination of Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients are out-patients recruited from Department of Hepatology, Aarhus University Hospital Healthy subjects are recruited via add in a local newspaper

Liver Cirrhosis
Not Provided
  • 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
Sørensen M, Munk OL, Mortensen FV, Olsen AK, Bender D, Bass L, Keiding S. Hepatic uptake and metabolism of galactose can be quantified in vivo by 2-[18F]fluoro-2-deoxygalactose positron emission tomography. Am J Physiol Gastrointest Liver Physiol. 2008 Jul;295(1):G27-G36. Epub 2008 May 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
16
May 2011
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • liver cirrhosis

Exclusion Criteria:

  • hepatic encephalopathy
  • pregnancy
Both
18 Years to 75 Years
Yes
Contact: Susanne Keiding, Prof, MD +45 89493031 ext 3031 susanne@pet.auh.dk
Contact: Michael Sørensen, PhD, MD +45 89493033 ext 3033 michael@pet.auh.dk
Denmark
 
NCT01002261
gal-FDGal, R01 DK 074419
No
Susanne Keiding (PI), Aarhus University Hospital, 8000 Aarhus C, Denmark
Aarhus University Hospital
Not Provided
Study Director: John Westensee, Mr Research Support Office, Aarhus University Hospital
Aarhus University Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP