Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-04-10 @ 3:41 AM
Study NCT ID:
NCT01002261
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2009-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-22', 'studyFirstSubmitDate': '2009-10-26', 'studyFirstSubmitQcDate': '2009-10-26', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lumped constant for recalculation of PET/CT data for FDGalactose to data for natural galactose', 'timeFrame': 'May 2011'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Galactose', 'PET/CT', 'Liver physiology', 'Liver pathophysiology'], 'conditions': ['Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '18483186', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nBased 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.\n\nBesides possible practical clinical importance, the project elucidates basic problems concerning liver metabolism using PET.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are out-patients recruited from Department of Hepatology, Aarhus University Hospital Healthy subjects are recruited via add in a local newspaper', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* liver cirrhosis\n\nExclusion Criteria:\n\n* hepatic encephalopathy\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01002261', 'briefTitle': 'Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Determination of Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects', 'orgStudyIdInfo': {'id': 'gal-FDGal'}, 'secondaryIdInfos': [{'id': 'R01DK074419', 'link': 'https://reporter.nih.gov/quickSearch/R01DK074419', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver cirrhosis / healthy subjects', 'description': '10 patients with liver cirrhosis and 10 sex and age-matched healthy subjects'}, {'label': 'Liver cirrhosis and healthy subjects', 'description': 'Patients with liver cirrhosis and healthy subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK 8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital, PET Centre', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'John Westensee, Mr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Research Support Office, Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Susanne Keiding (PI)', 'oldOrganization': 'Aarhus University Hospital, 8000 Aarhus C, Denmark'}}}}