Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-25 @ 5:55 PM
Study NCT ID:
NCT02336360
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2015-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Augmenting Flortaucipir Dosimetry Estimates
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': 'C000591008', 'term': '7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaloperations@avidrp.com', 'phone': '215-298-0700', 'title': 'Medical Director', 'organization': 'Avid Radiopharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were not collected in this study', 'description': 'No subjects were administered a drug in this study. Therefore, participants at risk for adverse events in this study is zero.', 'eventGroups': [{'id': 'EG000', 'title': 'Urine Analysis', 'description': 'Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Urine Analysis - Total Integrated Radioactivity Excreted in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Urine Analysis', 'description': 'Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1413', 'spread': '0.07216', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-360 minutes post injection', 'description': 'Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations.', 'unitOfMeasure': 'megabecquerel-hours per megabecquerel', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Urine Analysis', 'description': 'Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrollment occurred from Jan-Jun 2015 from Avid sponsored study 18F-AV-1451-A05 (NCT02016560)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Urine Analysis', 'description': 'Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2015-01-08', 'resultsFirstSubmitDate': '2020-07-27', 'studyFirstSubmitQcDate': '2015-01-12', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-27', 'studyFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine Analysis - Total Integrated Radioactivity Excreted in Urine', 'timeFrame': '0-360 minutes post injection', 'description': 'Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'This study will obtain data from urine in subjects administered flortaucipir in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who passed screening in an Avid-sponsored study in which flortaucipir will be administered\n\nExclusion Criteria:\n\n* Subjects who have withdrawn informed consent\n* Investigator or sponsor believes it is in the best interest of the subject to be removed from the trials'}, 'identificationModule': {'nctId': 'NCT02336360', 'briefTitle': 'Augmenting Flortaucipir Dosimetry Estimates', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avid Radiopharmaceuticals'}, 'officialTitle': 'A Multicenter Study to Obtain Data to Assist in Radiation Dosimetry Calculations From Subjects Enrolled in Human Studies Employing 18F-AV-1451', 'orgStudyIdInfo': {'id': '18F-AV-1451-A15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Urine Analysis', 'description': 'Urine will be collected from subjects administered flortaucipir in an Avid-sponsored study to determine the amount of radioactivity excreted in urine.', 'interventionNames': ['Drug: Flortaucipir F18']}], 'interventions': [{'name': 'Flortaucipir F18', 'type': 'DRUG', 'otherNames': ['18F-AV-1451', '[F-18]T807', 'LY3191748', 'Tauvid'], 'description': 'No flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study.', 'armGroupLabels': ['Urine Analysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Molecular NeuroImaging', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avid Radiopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}