Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT01564706
Status:
COMPLETED
Last Update Posted:
2012-05-18
First Post:
2012-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of 18F-AV-45 in Healthy Volunteers
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': '215-298-0700', 'title': 'Chief Medical Officer', 'organization': 'Avid Radiopharmaceuticals'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs occuring within 3 days of injection; SAEs occuring within 30 days of injection', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Volunteers', 'description': 'Single i.v. administration of approximately 10mCi 18F-AV-45', 'otherNumAtRisk': 9, 'otherNumAffected': 5, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Whole Body Radiation Dosimetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': 'Single i.v. administration of approximately 10mCi 18F-AV-45'}], 'classes': [{'title': 'Effective Dose', 'categories': [{'measurements': [{'value': '0.0186', 'spread': '0.00426', 'groupId': 'OG000'}]}]}, {'title': 'Adrenals', 'categories': [{'measurements': [{'value': '0.0136', 'spread': '0.00129', 'groupId': 'OG000'}]}]}, {'title': 'Brain', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.00186', 'groupId': 'OG000'}]}]}, {'title': 'Breasts', 'categories': [{'measurements': [{'value': '0.00624', 'spread': '0.000865', 'groupId': 'OG000'}]}]}, {'title': 'Gallbladder Wall', 'categories': [{'measurements': [{'value': '0.143', 'spread': '0.0802', 'groupId': 'OG000'}]}]}, {'title': 'Lower Large Intestine Wall', 'categories': [{'measurements': [{'value': '0.0278', 'spread': '0.0102', 'groupId': 'OG000'}]}]}, {'title': 'Small Intestine', 'categories': [{'measurements': [{'value': '0.0655', 'spread': '0.0296', 'groupId': 'OG000'}]}]}, {'title': 'Stomach Wall', 'categories': [{'measurements': [{'value': '0.0117', 'spread': '0.000906', 'groupId': 'OG000'}]}]}, {'title': 'Upper Large Intestine Wall', 'categories': [{'measurements': [{'value': '0.0745', 'spread': '0.0342', 'groupId': 'OG000'}]}]}, {'title': 'Heart Wall', 'categories': [{'measurements': [{'value': '0.0131', 'spread': '0.00159', 'groupId': 'OG000'}]}]}, {'title': 'Kidneys', 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.00111', 'groupId': 'OG000'}]}]}, {'title': 'Liver', 'categories': [{'measurements': [{'value': '0.0644', 'spread': '0.0221', 'groupId': 'OG000'}]}]}, {'title': 'Lungs', 'categories': [{'measurements': [{'value': '0.00852', 'spread': '0.000801', 'groupId': 'OG000'}]}]}, {'title': 'Muscle', 'categories': [{'measurements': [{'value': '0.00863', 'spread': '0.000762', 'groupId': 'OG000'}]}]}, {'title': 'Ovaries', 'categories': [{'measurements': [{'value': '0.0176', 'spread': '0.00434', 'groupId': 'OG000'}]}]}, {'title': 'Pancreas', 'categories': [{'measurements': [{'value': '0.0144', 'spread': '0.00134', 'groupId': 'OG000'}]}]}, {'title': 'Red Marrow', 'categories': [{'measurements': [{'value': '0.0143', 'spread': '0.00178', 'groupId': 'OG000'}]}]}, {'title': 'Osteogenic Cells', 'categories': [{'measurements': [{'value': '0.0276', 'spread': '0.00371', 'groupId': 'OG000'}]}]}, {'title': 'Skin', 'categories': [{'measurements': [{'value': '0.00593', 'spread': '0.000809', 'groupId': 'OG000'}]}]}, {'title': 'Spleen', 'categories': [{'measurements': [{'value': '0.0089', 'spread': '0.000986', 'groupId': 'OG000'}]}]}, {'title': 'Testes', 'categories': [{'measurements': [{'value': '0.00681', 'spread': '0.00129', 'groupId': 'OG000'}]}]}, {'title': 'Thymus', 'categories': [{'measurements': [{'value': '0.00727', 'spread': '0.00122', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid', 'categories': [{'measurements': [{'value': '0.00675', 'spread': '0.00143', 'groupId': 'OG000'}]}]}, {'title': 'Urinary Bladder Wall', 'categories': [{'measurements': [{'value': '0.0271', 'spread': '0.0117', 'groupId': 'OG000'}]}]}, {'title': 'Uterus', 'categories': [{'measurements': [{'value': '0.0156', 'spread': '0.00319', 'groupId': 'OG000'}]}]}, {'title': 'Total Body', 'categories': [{'measurements': [{'value': '0.0116', 'spread': '0.000951', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-380 min after injection', 'description': 'Radiation dose values (millisieverts/megabecquerel \\[mSv/MBq\\]) for regions of the whole body. Target organs included the adrenals, brain, breasts, gall bladder wall, lower large intestine wall, small intestine wall, stomach wall, upper large intestine wall, heart wall, kidneys, liver, lungs, muscle, ovaries, pancreas, osteogenic cells, skin, spleen, testes, thymus, thyroid, urinary bladder wall, uterus, and total body.', 'unitOfMeasure': 'mSv/MBq', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Volunteers', 'description': 'Single i.v. administration of approximately 10mCi 18F-AV-45'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Volunteers', 'description': 'Single i.v. administration of approximately 10mCi 18F-AV-45'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'spread': '10.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', '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': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-11', 'studyFirstSubmitDate': '2012-03-25', 'resultsFirstSubmitDate': '2012-04-03', 'studyFirstSubmitQcDate': '2012-03-25', 'lastUpdatePostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-03', 'studyFirstPostDateStruct': {'date': '2012-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole Body Radiation Dosimetry', 'timeFrame': '0-380 min after injection', 'description': 'Radiation dose values (millisieverts/megabecquerel \\[mSv/MBq\\]) for regions of the whole body. Target organs included the adrenals, brain, breasts, gall bladder wall, lower large intestine wall, small intestine wall, stomach wall, upper large intestine wall, heart wall, kidneys, liver, lungs, muscle, ovaries, pancreas, osteogenic cells, skin, spleen, testes, thymus, thyroid, urinary bladder wall, uterus, and total body.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amyloid imaging', 'Positron Emission Tomography', '18F-AV-45', 'florbetapir F 18', 'Diagnostic imaging'], 'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to lie still on the imaging table for periods up to 1 hour\n\nExclusion Criteria:\n\n* Radiation exposure for experimental purposes within the last year\n* Claustrophobic or otherwise unable to tolerate the imaging procedure\n* Medical condition or surgical history that would confound evaluation\n* Current clinically significant cardiovascular disease\n* Received an investigational medication within the last 30 days'}, 'identificationModule': {'nctId': 'NCT01564706', 'briefTitle': 'A Study of 18F-AV-45 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avid Radiopharmaceuticals'}, 'officialTitle': 'Positron Emission Tomography Whole Body Biodistribution Using 18F-AV-45', 'orgStudyIdInfo': {'id': '18F-AV-45-A02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteers', 'description': 'Healthy male or female subjects, between 18 and 85 years of age.', 'interventionNames': ['Drug: florbetapir F 18']}], 'interventions': [{'name': 'florbetapir F 18', 'type': 'DRUG', 'otherNames': ['18F-AV-45', 'Amyvid', 'florbetapir'], 'description': 'IV injection, 370MBq (10mCi), single dose', 'armGroupLabels': ['Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19406', 'city': 'Jenkintown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.09594, 'lon': -75.12517}}], 'overallOfficials': [{'name': 'Chief Medical Officer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avid Radiopharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avid Radiopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}