Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-27 @ 10:37 AM
Study NCT ID:
NCT03040427
Status:
TERMINATED
Last Update Posted:
2021-07-27
First Post:
2017-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028227', 'term': 'Amyloid Neuropathies, Familial'}], 'ancestors': [{'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017772', 'term': 'Amyloid Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D028226', 'term': 'Amyloidosis, Familial'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545186', 'term': 'florbetapir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jaberw@ccf.org', 'phone': '216.444.8305', 'title': 'Dr. Wael A. Jaber', 'organization': 'Cleveland Clinic Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'At Risk for Symptomatic AL Cardiac Amyloidosis', 'description': 'Patients with MGUS at risk for developing AL amyloidosis', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'At Risk for Symptomatic ATTR Cardiac Amyloidosis', 'description': 'Patients with biopsy proven extra-cardiac ATTR amyloidosis', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Patients', 'description': 'Negative carpal tunnel biopsy', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quantitative Myocardial F18-florbetapir Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'At Risk for Symptomatic AL Cardiac Amyloidosis', 'description': 'Patients with MGUS at risk for developing AL amyloidosis'}, {'id': 'OG001', 'title': 'At Risk for Symptomatic ATTR Cardiac Amyloidosis', 'description': 'Patients with biopsy proven extra-cardiac ATTR amyloidosis'}, {'id': 'OG002', 'title': 'Control Patients', 'description': 'Negative carpal tunnel biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at the time of the PET scan', 'description': 'Number of participants with quantitative F18-florbetapir uptake above previously defined control values', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants had quantitative uptake of F18-Flobetapir'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'At Risk for Symptomatic AL Cardiac Amyloidosis', 'description': 'Patients with MGUS at risk for developing AL amyloidosis'}, {'id': 'FG001', 'title': 'At Risk for Symptomatic ATTR Cardiac Amyloidosis', 'description': 'Patients with biopsy proven extra-cardiac ATTR amyloidosis'}, {'id': 'FG002', 'title': 'Control Patients', 'description': 'Negative carpal tunnel biopsy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'At Risk for Symptomatic AL Cardiac Amyloidosis', 'description': 'Patients with MGUS at risk for developing AL amyloidosis'}, {'id': 'BG001', 'title': 'At Risk for Symptomatic ATTR Cardiac Amyloidosis', 'description': 'Patients with biopsy proven extra-cardiac ATTR amyloidosis'}, {'id': 'BG002', 'title': 'Control Patients', 'description': 'Negative carpal tunnel biopsy'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '71.4', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '72', 'spread': '6.9', 'groupId': 'BG002'}, {'value': '72', 'spread': '5.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-22', 'size': 990167, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-10T13:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2017-01-31', 'resultsFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-07', 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative Myocardial F18-florbetapir Uptake', 'timeFrame': 'at the time of the PET scan', 'description': 'Number of participants with quantitative F18-florbetapir uptake above previously defined control values'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['F-18 florbetapir', 'Amyvid', 'PET scan', 'Early detection'], 'conditions': ['Cardiac Amyloidosis']}, 'descriptionModule': {'briefSummary': 'The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.', 'detailedDescription': "F-18 florbetapir is currently used for the early detection of brain amyloid (Alzheimer's disease). The hypothesis is that F-18 florbetapir will detect amyloid deposition in myocardium prior to current non-invasive diagnostic measures, particular electrocardiography with strain and technetium pyrophosphate scintigraphy. The investigators intend to use F-18 florbetapir and assess its correlation between standard non-invasive diagnostic modalities."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis\n2. Patients with a ratio of affected to unaffected free light chains \\>5 or free light chain difference of \\>50\n\nExclusion Criteria:\n\n1. Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm\n2. Contraindication to florbetapir or its components\n3. Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT03040427', 'briefTitle': 'The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis', 'orgStudyIdInfo': {'id': '16-960'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AL or TTR type amyloidosis', 'description': 'The participants will undergo F-18 florbetapir PET scan.', 'interventionNames': ['Drug: F-18 florbetapir']}], 'interventions': [{'name': 'F-18 florbetapir', 'type': 'DRUG', 'otherNames': ['Amyvid', 'Florbetapir-fluorine-18', '18F-AV-45'], 'description': 'Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).', 'armGroupLabels': ['AL or TTR type amyloidosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation (Main Campus)', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Steven Nissen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Wael Jaber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Avid Radiopharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}