Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-04-05 @ 6:41 AM
Study NCT ID:
NCT01265394
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2010-12-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects
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': 'C581552', 'term': 'flutemetamol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'paulsherwin@ge.com', 'phone': '1-609-514-6820', 'title': 'Dr. Paul Sherwin', 'organization': 'GE Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '(18F) Flutemetamol', 'description': '\\[18F\\] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.', 'otherNumAtRisk': 181, 'otherNumAffected': 27, 'seriousNumAtRisk': 181, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'General Disorders and Administration Site Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vascular System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vascular System Disorders-Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal and Abnormal Reads With or Without Amyloid', 'description': 'Each Subject received a dose of \\[18F\\] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.'}], 'classes': [{'title': 'Reader 1 -Normal Read-no amyloid', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000', 'lowerLimit': '98.0', 'upperLimit': '100.0'}]}]}, {'title': 'Reader 1- Abnormal Read- amyloid is present', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '60.6', 'upperLimit': '74.7'}]}]}, {'title': 'Reader 2 - Normal Read-no amyloid', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}]}]}, {'title': 'Reader 2 - Abnormal Read-amyloid is present', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}]}]}, {'title': 'Reader 3 - Normal Read-no amyloid', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.9'}]}]}, {'title': 'Reader 3 - Abnormal Read-amyloid is present', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Reader 4 - Normal Read-no amyloid', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}]}]}, {'title': 'Reader 4 - Abnormal Read-amyloid is present', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Reader 5 - Normal Read-no amyloid', 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}]}]}, {'title': 'Reader 5 - Abnormal Read-amyloid is present', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PET scans performed on patients 90 minutes post Flutemetmol Administration', 'description': 'The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging.\n\nThe measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading).', 'unitOfMeasure': 'Brain Scans Read', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy young adult subjects aged 18 to 40 are presumed to be amyloid negative'}, {'type': 'SECONDARY', 'title': 'Measurement of Amyloid Content in Different Parts of the Brain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '(18F) Flutemetamol Injection', 'description': 'Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.'}], 'classes': [{'title': 'Cerebullum Region', 'categories': [{'measurements': [{'value': '1.12', 'spread': '0.097', 'groupId': 'OG000', 'lowerLimit': '1.108', 'upperLimit': '1.136'}]}]}, {'title': 'Pons Region', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.036', 'groupId': 'OG000', 'lowerLimit': '0.487', 'upperLimit': '0.498'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'PET scans performed on patients 90 minutes post Flutemetmol Administration', 'description': 'Is the computerized measurement of amyloid content in different parts of the brain.\n\nThe Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection.\n\nThe Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions.\n\nThe Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.', 'unitOfMeasure': 'Standard Uptake Value Ratio ( SUVR)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '(18F) Flutemetamol', 'description': '\\[18F\\] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Subjects withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '(18F) Flutemetamol', 'description': '\\[18F\\] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '181', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '5.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This is the number of participants that completed.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-21', 'studyFirstSubmitDate': '2010-12-21', 'resultsFirstSubmitDate': '2013-03-27', 'studyFirstSubmitQcDate': '2010-12-21', 'lastUpdatePostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-14', 'studyFirstPostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid', 'timeFrame': 'PET scans performed on patients 90 minutes post Flutemetmol Administration', 'description': 'The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging.\n\nThe measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading).'}], 'secondaryOutcomes': [{'measure': 'Measurement of Amyloid Content in Different Parts of the Brain', 'timeFrame': 'PET scans performed on patients 90 minutes post Flutemetmol Administration', 'description': 'Is the computerized measurement of amyloid content in different parts of the brain.\n\nThe Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection.\n\nThe Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions.\n\nThe Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amyloid', 'Magnetic resonance imaging', 'Positron Emission Tomography', 'Standard uptake value ratios', 'Healthy Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject age is 18 to 40 years.\n* The subject has no evidence of thinking or memory problems by medical history.\n* The subject has a normal MRI scan.\n* The subject's general health is adequate to comply with study procedures.\n* The subject is willing and able to participate in all study procedures.\n\nExclusion Criteria:\n\n* The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT).\n* The subject has a contraindication for (cannot undergo) MRI.\n* The subject has a history of head injury with loss of consciousness.\n* The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology.\n* The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative."}, 'identificationModule': {'nctId': 'NCT01265394', 'briefTitle': 'Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'A Single-arm, Open-label, Multi-center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40', 'orgStudyIdInfo': {'id': 'GE-067-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(18F) Flutemetamol', 'interventionNames': ['Drug: [18F] Flutemetamol']}], 'interventions': [{'name': '[18F] Flutemetamol', 'type': 'DRUG', 'otherNames': ['AH110690'], 'description': 'Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.', 'armGroupLabels': ['(18F) Flutemetamol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GE Healthcare', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}], 'overallOfficials': [{'name': 'Paul Sherwin, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GE Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'i3 Statprobe', 'class': 'INDUSTRY'}, {'name': 'Medpace, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}