Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-02-27 @ 2:21 PM
Study NCT ID:
NCT01879735
Status:
COMPLETED
Last Update Posted:
2015-02-23
First Post:
2013-06-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}, {'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C061997', 'term': 'cholylsarcosine'}, {'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'susanne@pet.auh.dk', 'phone': '+45 7846 3031', 'title': 'Susanne Keiding M.D., Associate professor, D.Sc.', 'organization': 'Dept. of Nuclear Medicine & PET-center, Dept. of Hepatology and Gastroenterolgy. Aarhus University Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Subjects were observed during the PET/CT recordings and for 2 hours after the final PET/CT-recording.', 'description': 'A minor physical examination with blood pressure and puls was performed by a doctor or nurse every 30 minutes for at lest 2 hours after the last PET/CT recording.', 'eventGroups': [{'id': 'EG000', 'title': "ICG's Effect on 11C-CSar Transport", 'description': 'Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bolus vs. Constant Infusion', 'description': 'Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ICG Infusion', 'description': 'Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.'}, {'id': 'OG001', 'title': 'Infusion Method', 'description': 'Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All measurements are performed in one day.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ICG Infusion', 'description': 'Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.'}, {'id': 'FG001', 'title': 'Bolus and Constant Infusion of 11C-CSar', 'description': 'Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '10 healthy subjects were recruided after they responded to an advertisement in the local newspaper.\n\n12 patients with varying degree of cholestasis and different underlying diseases were recruided from the Department of hepatology and gastroenterology Aarhus University Hospital.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "ICG's Effect on 11C-CSar Transport", 'description': 'Examine the effect of indocyanine green (ICG) on the rate constants for the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.'}, {'id': 'BG001', 'title': 'Bolus vs. Constant Infusion', 'description': 'Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-04', 'studyFirstSubmitDate': '2013-06-11', 'resultsFirstSubmitDate': '2015-01-19', 'studyFirstSubmitQcDate': '2013-06-13', 'lastUpdatePostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-04', 'studyFirstPostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar', 'timeFrame': 'All measurements are performed in one day.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cholestasis', 'Primary Sclerosing Cholangitis', 'Primary Biliary Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '28249726', 'type': 'DERIVED', 'citation': 'Orntoft NW, Munk OL, Frisch K, Ott P, Keiding S, Sorensen M. Hepatobiliary transport kinetics of the conjugated bile acid tracer 11C-CSar quantified in healthy humans and patients by positron emission tomography. J Hepatol. 2017 Aug;67(2):321-327. doi: 10.1016/j.jhep.2017.02.023. Epub 2017 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'We wish to develop a protocol for PET/CT examination of humans using the bile acid tracer 11C-cholylsarcosine. This is done by a series of PET/CT examinations of healthy humans and patients with cholestatic disorders.', 'detailedDescription': 'The purpose of the study is the development of PET/CT protocols using 11C-CSar for human use. PET/CT methods developed in the pig studies are translated to studies in healthy humans and patients with cholestatic disorders. Dynamic PET/CT scans of the liver and biliary system are combined with measurements of tracer concentrations in a radial artery and a liver vein and measurements of hepatic blood flow by intravenous infusion of indocyanine green (ICG)/Ficks principle. Kinetic parameters from PET/CT measurements and invasive measurements are compared for validation of the PET estimated parameters and refinement of the PET modeling, if required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cholestatic disorders and healthy subjects\n\nExclusion Criteria:\n\n* Body weight above 110 kg (catheterization problematic).\n* Diabetes\n* Pregnant or breast feeding women.'}, 'identificationModule': {'nctId': 'NCT01879735', 'briefTitle': 'Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Hepatic Transport of Conjugated Bile Acids in Humans Quantified by 11C-cholylsarcosine PET/CT', 'orgStudyIdInfo': {'id': 'C-CSar humane 244'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "ICG's effect on 11C-CSar transport", 'description': 'Examine the effect of ICG on the kinetics of the hepatic transport of 11C-CSar. If no effect is seen on the kinetics, ICG will be used during the "infusion method" experiments.', 'interventionNames': ['Drug: 11C-CSar', 'Drug: ICG']}, {'type': 'EXPERIMENTAL', 'label': 'Infusion method', 'description': 'Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. If ICG does not affect the kinetics of 11C-CSar it will be used during these experiments to calculate hepatic blood flow.', 'interventionNames': ['Drug: 11C-CSar', 'Drug: ICG']}], 'interventions': [{'name': '11C-CSar', 'type': 'DRUG', 'otherNames': ['11C-cholylsarcosine'], 'description': 'PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids.', 'armGroupLabels': ["ICG's effect on 11C-CSar transport", 'Infusion method']}, {'name': 'ICG', 'type': 'DRUG', 'otherNames': ['indocyanine green'], 'description': 'Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar.', 'armGroupLabels': ["ICG's effect on 11C-CSar transport", 'Infusion method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'state': 'Aarhus C', 'country': 'Denmark', 'facility': 'Department of Nuclear medicine and PET-center', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Susanne Keiding, M.D. D.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}