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
  Purpose

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
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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
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)
Groups/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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

Criteria

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 ClinicalTrials.gov identifier: NCT01002261

Contacts
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

Locations
Denmark
Aarhus University Hospital, PET Centre Not yet recruiting
Aarhus, Denmark, DK 8000
Contact: John Westensee, Dr.    +45 89492379      
Principal Investigator: Susanne Keiding, Prof., MD         
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Study Director: John Westensee, Mr Research Support Office, Aarhus University Hospital
  More Information

Additional Information:
Publications:
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, R01 DK 074419
Study First Received: October 26, 2009
Last Updated: October 26, 2009
Health Authority: Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:
Galactose
PET/CT
Liver physiology
Liver pathophysiology

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014