Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-29 @ 9:22 PM
Study NCT ID:
NCT01767493
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2012-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545186', 'term': 'florbetapir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'spizarro@invicro.com', 'phone': '203-990-1613', 'title': 'Stephanie Pizarro', 'organization': 'Invicro'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for 1 year.', 'description': 'There were three adverse events and all three were considered to be unrelated to the imaging or other study procedures.', 'eventGroups': [{'id': 'EG000', 'title': '[18F]Florbetapir PET Imaging', 'description': '\\[18F\\]Florbetapir and PET imaging', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 2, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Wrist Pain', 'notes': 'The pain was deemed unrelated to imaging or other study procedures. The pain was mild and not limiting.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Wall Congestion', 'notes': 'The adverse event was mild. The adverse event was deemed unrelated to imaging or other study procedures. The AE has been resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal Reflux', 'notes': 'The adverse event was mild and deemed unrelated to imaging or other study procedures. The AE has been resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Number of Lesions Detected by [18F]Florbetapir PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[18F]Florbetapir PET Imaging', 'description': '\\[18F\\]Florbetapir and PET imaging'}], 'classes': [{'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'This study demonstrates the feasibility of\\[18F\\]Florbetapir PET for identifying demyelinating lesions in relapsing-remitting MS patients. It was expected that lesion size played a factor in identifying white matter lesions with those smaller than 5 mm less evident on PET. Using spherical volumes of interest the extent of reduction in the white matter uptake can be reliably quantified. This requires careful attention to techniques for sampling in both the lesions and white matter control regions for the subject.', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '[18F]Florbetapir Imaging', 'description': '\\[18F\\]Florbetapir and PET imaging'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'screen failures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '[18F]Florbetapir PET Imaging', 'description': '\\[18F\\]Florbetapir and PET imaging'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-26', 'studyFirstSubmitDate': '2012-12-13', 'resultsFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2013-01-10', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-25', 'studyFirstPostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Lesions Detected by [18F]Florbetapir PET', 'timeFrame': '1 year', 'description': 'This study demonstrates the feasibility of\\[18F\\]Florbetapir PET for identifying demyelinating lesions in relapsing-remitting MS patients. It was expected that lesion size played a factor in identifying white matter lesions with those smaller than 5 mm less evident on PET. Using spherical volumes of interest the extent of reduction in the white matter uptake can be reliably quantified. This requires careful attention to techniques for sampling in both the lesions and white matter control regions for the subject.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.indd.org', 'label': 'Institute for Neurodegenerative Disorders'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility of \\[18F\\]Florbetapir positron emission tomography (PET) for assessment of demyelination in the patients with relapsing remitting multiple sclerosis.', 'detailedDescription': 'The underlying goal of this study is to assess the feasibility of \\[18F\\]Florbetapir as an imaging tool to detect demyelination in the brain of MS research participants and compare to similarly aged healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Eligibility criteria (for all subjects):\n\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations\n* Willingness to comply with study procedures\n* Willingness to provide written informed consent\n* Age greater than or equal to 18 and less than or equal to 60 years old at the time of the informed consent\n* Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception until PET testing is completed\n* For females, must be of non-childbearing potential or have a negative urine and blood pregnancy test on the day of \\[18F\\]Florbetapir PET injection\n\nInclusion Criteria (Healthy Volunteers):\n\n* No history of or signs of acute or chronic neurological or psychiatric illness based on evaluation by a research physician.\n\nInclusion Criteria (MS Subjects):\n\n* Have a diagnosis of relapsing remitting MS according to the 2010 MacDonald Criteria\n* Have at least 10 demyelinating lesion on brain MRI with the following characteristics:\n* Hypointense on T2 weighted images with FLAIR\n\nExclusion Criteria (for all subjects):\n\n* The subject has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness\n* The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological (other than RRMS), immunodeficiency, pulmonary, or other disorder or disease.\n* Women who are pregnant or actively breastfeeding\n* The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)\n* The subject has participated in another clinical study within the previous 30 days\n* Renal impairment with a creatine clearance \\<80mL/minute at screening (creatine clearance estimated by Cockcroft-Gault equation)\n* The subject is scheduled to have a major surgery or procedure during the time of the study.'}, 'identificationModule': {'nctId': 'NCT01767493', 'briefTitle': 'Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Institute for Neurodegenerative Disorders'}, 'officialTitle': 'An Open-label, Non-randomized Study to Evaluate the Feasibility of [18F]Florbetapir Positron Emission Tomography (PET) for Assessment of Demyelination in Patients With Relapsing Remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'Florbetapir MS 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[18F]Florbetapir PET imaging', 'description': '\\[18F\\]Florbetapir and PET imaging', 'interventionNames': ['Drug: [18F]Florbetapir PET imaging']}], 'interventions': [{'name': '[18F]Florbetapir PET imaging', 'type': 'DRUG', 'otherNames': ['Amyvid'], 'description': '\\[18F\\]Florbetapir and PET imaging', 'armGroupLabels': ['[18F]Florbetapir PET imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Institute for Neurodegenerative Disorders', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Danna Jennings, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Neurodegenerative Disorders'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Neurodegenerative Disorders', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}