Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT01565369
Status:
COMPLETED
Last Update Posted:
2012-06-07
First Post:
2012-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Physician Training Methods to Read Florbetapir-PET Scans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545186', 'term': 'florbetapir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaloperations@avidrp.com', 'phone': '215-798-0700', 'title': 'Chief Medical Officer', 'organization': 'Avid Radiopharmaceuticals'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'No subjects received florbetapir in this study. This study consisted of rereads of scans previously acquired in another clinical study (A07).', 'eventGroups': [{'id': 'EG000', 'title': 'All A07 Autopsy Subjects', 'description': 'Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All A07(NCT00857415) Autopsy Subjects', 'description': 'Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '84.2', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '50-60 min after injection', 'description': 'Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers.', 'unitOfMeasure': 'percentage of true positives', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '19 of the 35 subjects had moderate or frequent plaques at autopsy'}, {'type': 'PRIMARY', 'title': 'Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All A07 Autopsy Subjects', 'description': 'Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)'}], 'classes': [{'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '68.8', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '50-60 min after injection', 'description': 'Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Specificity will be calculated as the percent of true negatives (as determined by the reference standard, no or sparse amyloid plaque at autopsy) that are correctly identified as amyloid negative by the PET scan read. Reported as the median specificity of the nine readers.', 'unitOfMeasure': 'percentage of true negatives', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '16 of the 35 subjects had none or sparse plaques at autopsy'}, {'type': 'SECONDARY', 'title': 'Inter-reader Agreement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'florbetapir PET scan reads', 'counts': [{'value': '315', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All A07(NCT00857415) Autopsy Subjects', 'description': 'Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)'}], 'classes': [{'title': 'Agreed with majority read', 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000'}]}]}, {'title': 'Discrepant with majority read', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': "Fleiss' kappa", 'ciPctValue': '95', 'paramValue': '0.8547', 'pValueComment': 'evaluated at the .05 significance level', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0282', 'groupDescription': "Fleiss' kappa", 'statisticalMethod': "Fleiss' kappa", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '50-60 min after injection', 'description': 'Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers', 'unitOfMeasure': 'percentage of scans', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'florbetapir PET scan reads', 'denomUnitsSelected': 'Participants', 'populationDescription': '315 scans = 35 subjects x 9 readers'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All A07 Autopsy Subjects', 'description': 'Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained in other clinical studies'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All A07 Autopsy Subjects', 'description': 'Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '79.3', 'spread': '13.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-03', 'studyFirstSubmitDate': '2012-03-26', 'resultsFirstSubmitDate': '2012-04-06', 'studyFirstSubmitQcDate': '2012-03-27', 'lastUpdatePostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-03', 'studyFirstPostDateStruct': {'date': '2012-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque', 'timeFrame': '50-60 min after injection', 'description': 'Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers.'}, {'measure': 'Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque', 'timeFrame': '50-60 min after injection', 'description': 'Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Specificity will be calculated as the percent of true negatives (as determined by the reference standard, no or sparse amyloid plaque at autopsy) that are correctly identified as amyloid negative by the PET scan read. Reported as the median specificity of the nine readers.'}], 'secondaryOutcomes': [{'measure': 'Inter-reader Agreement', 'timeFrame': '50-60 min after injection', 'description': 'Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amyloid imaging', 'Positron Emission Tomography', '18F-AV-45', 'florbetapir F 18', 'Diagnostic imaging'], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is re-read of brain amyloid positron emission tomography (PET) scans acquired in previous florbetapir F 18 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had an autopsy to reveal the subject's true amyloid status."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (Study A07\\[NCT00857415\\]):\n\n* Have a projected life expectancy of ≤ 6 months as determined by the principal investigator (e.g. terminal medical condition) or are already enrolled in a longitudinal study of aging with an autopsy component;\n* Can tolerate a 10 minute PET scan; and\n* Give informed consent for study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die.\n\nExclusion Criteria (Study A07\\[NCT00857415\\]):\n\n* Have primary brain tumor, known metastases to the brain, central nervous system (CNS) lymphoma;\n* Have any major, focal structural loss of brain matter;\n* Are aggressively being treated with life sustaining measures (e.g. currently on respirator; receiving high dose chemotherapy);\n* Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);\n* Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;\n* Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, secretase inhibitor);\n* Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or\n* Are females of childbearing potential who are pregnant or not using adequate contraception.'}, 'identificationModule': {'nctId': 'NCT01565369', 'briefTitle': 'Evaluation of Physician Training Methods to Read Florbetapir-PET Scans', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avid Radiopharmaceuticals'}, 'officialTitle': 'Evaluation of Physician Training for Interpretation of Florbetapir-PET Scans: Validation of Binary Image Rating Methodology Using Amyloid Histopathology at Autopsy as the Reference Standard.', 'orgStudyIdInfo': {'id': '18F-AV-45-A08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'florbetapir F 18', 'type': 'DRUG', 'otherNames': ['18F-AV-45', 'Amyvid', 'florbetapir'], 'description': 'IV injection, 370MBq (10mCi), single dose'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chief Medical Officer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avid Radiopharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avid Radiopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}