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

NCT01002261 | Completed

• 2 other identifiers: gal-FDGalR01DK074419
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis

Keywords

Galactose; PET/CT; Liver physiology; Liver pathophysiology

Outcome Measures

Primary Outcomes (1)

• Lumped constant for recalculation of PET/CT data for FDGalactose to data for natural galactose

  May 2011

Study Arms (2)

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 Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• liver cirrhosis

You may not qualify if:

• hepatic encephalopathy
• pregnancy

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital, PET Centre

Aarhus, DK 8000, Denmark

Location

Related Publications (1)

• Sorensen 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. doi: 10.1152/ajpgi.00004.2008. Epub 2008 May 15.

  PMID: 18483186 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Westensee, Mr

  Research Support Office, Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 27, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 26, 2015

Record last verified: 2009-10

Locations

DK (1)