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

NCT ID: NCT01002261

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-01-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Liver cirrhosis / healthy subjects

10 patients with liver cirrhosis and 10 sex and age-matched healthy subjects

No interventions assigned to this group

Liver cirrhosis and healthy subjects

Patients with liver cirrhosis and healthy subjects

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• liver cirrhosis

Exclusion Criteria

• hepatic encephalopathy
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aarhus University Hospital, 8000 Aarhus C, Denmark

Principal Investigators

John Westensee, Mr

Role: STUDY_DIRECTOR

Research Support Office, Aarhus University Hospital

Locations

Aarhus University Hospital, PET Centre

Aarhus, , Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 18483186 (View on PubMed)

Other Identifiers

R01DK074419

Identifier Type: NIH

Identifier Source: secondary_id

View Link

gal-FDGal

Identifier Type: -

Identifier Source: org_study_id