Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT01729169
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2012-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012507', 'term': 'Sarcoidosis'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2012-11-13', 'studyFirstSubmitQcDate': '2012-11-13', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac sarcoidosis - Sensitivity', 'timeFrame': '01/01/2015', 'description': 'Ability to correctly identify patients with cardiac sarcoidosis'}], 'secondaryOutcomes': [{'measure': 'Myocardial cardiac glucose uptake assessed by Cardiac SUV', 'timeFrame': '01/01/2015', 'description': 'Semiquantitative assessment of myocardial glucose uptake, the Standardized Uptake Value (SUV). Expressed in g/ml.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sarcoidosis', 'Cardiac sarcoidosis', '18-FDG PET', '68Ga-DOTANOC PET'], 'conditions': ['Sarcoidosis', 'Cardiac Sarcoidosis']}, 'referencesModule': {'references': [{'pmid': '27316444', 'type': 'DERIVED', 'citation': 'Gormsen LC, Haraldsen A, Kramer S, Dias AH, Kim WY, Borghammer P. A dual tracer (68)Ga-DOTANOC PET/CT and (18)F-FDG PET/CT pilot study for detection of cardiac sarcoidosis. EJNMMI Res. 2016 Dec;6(1):52. doi: 10.1186/s13550-016-0207-6. Epub 2016 Jun 17.'}]}, 'descriptionModule': {'briefSummary': "Diagnosing cardiac sarcoidosis has always been challenging: No single imaging modality has proved effective and cardiac biopsies have a very low sensitivity. 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET preceded by at least 12 hours of fasting has previously been demonstrated to have reasonable accuracy, however, in some patients physiological FDG uptake in the cardiac region hampers correct identification of sarcoid granulomas. Gallium Ga 68-DOTANOC is a conjugate of the somatostatin analogue Nal3-octreotide (NOC) and gallium Ga 68-labeled 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA). We aim to study whether 68Ga-DOTANOC has superior sensitivity and accuracy than 18-FDG PET in diagnosing cardiac sarcoidosis. In addition, we aim to compare 18-FDG PET preceded by 12 hours fasting with 18-FDG PET during somatostatin blockade of insulin mediated cardiac glucose uptake.", 'detailedDescription': 'Intervention:\n\n* Study A: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement (prone to arrhythmias, cardiac failure, unexplained dyspnea) are studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 18-FDG PET performed during a 2 hour somatostatin blockade (300 microgram/hour)/Heparin infusion.\n* Study B: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement are studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 68Ga-DOTANOC PET preceded by at least 6 hours fasting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy proven sarcoidosis\n* Suspected cardiac sarcoidosis\n\nExclusion Criteria:\n\n* Ischemic heart disease\n* Diabetes\n* Cardiomyopathy'}, 'identificationModule': {'nctId': 'NCT01729169', 'briefTitle': 'Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Diagnosing Cardiac Sarcoidosis Using FDG PET: Optimization', 'orgStudyIdInfo': {'id': 'SarcoidosisPET'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sarcoidosis patients', 'description': 'Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lars Christian Gormsen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant, MD PhD', 'investigatorFullName': 'Lars Christian Gormsen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}