Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-27 @ 12:50 AM
Study NCT ID:
NCT02343757
Status:
TERMINATED
Last Update Posted:
2022-05-12
First Post:
2014-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Not enough patient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2016-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2014-05-08', 'studyFirstSubmitQcDate': '2015-01-21', 'lastUpdatePostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measurement of Effect (ability of 18F-florbetapir (AMYVID) PET/MRI to assess the diagnosis of a patient, compared to both PET/CT and the diagnosis from the clinical record)', 'timeFrame': 'within one year', 'description': 'The main effect that will be evaluated in this study is the ability of 18F-florbetapir (AMYVID) PET/MRI to assess the diagnosis of a patient, compared to both PET/CT and the diagnosis from the clinical record. Another effect that will be evaluated is if there is an added value when using 18F-florbetapir (AMYVID) in addition to 2-\\[F-18\\]-fluoro-2 deoxy-D-glucose (FDG) versus using only FDG in the evaluation of cognitive impairment patients.'}], 'primaryOutcomes': [{'measure': 'To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.', 'timeFrame': 'within one year', 'description': 'To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone.', 'timeFrame': 'within one year', 'description': '2\\. To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-\\[F-18\\]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque burden correlate with degree of neuronal degeneration as depicted by FDG as well as with clinical severity?'}, {'measure': 'To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application;', 'timeFrame': 'within one year', 'description': '3\\. To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid (Philips Research, Hamburg)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dementia', 'Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'The early detection of a preclinical AD or early stage of AD with amyloid imaging could improve the diagnosis and provide knowledge for better therapeutical approach by combining the best of imaging: structural MR sequences and newly FDA-approved biomarker for amyloid PET imaging, all these two techniques with their strengths in one machine.\n\nSpecific Aims and Hypotheses can be summarized as follows:\n\n1. To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.\n2. To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-\\[F-18\\]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque burden correlate with degree of neuronal degeneration as depicted by FDG as well as with clinical severity?\n3. To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected AD, MCI and other cognitive impairment will be referred by their neurologist to have a clinical ordered FDG-PET/CT and clinically indicated AMYVID in addition,\n* Patients equal to or greater than 21 years old,\n* Signed informed consent by patient or legal guardian,\n* Physically capable to cooperate.\n\nExclusion Criteria:\n\n* Subjects who do not meet the above mentioned inclusion criteria,\n* Subjects unwilling or unable to sign the informed consent form,\n* Subjects with any significant psychiatric or neurologic disorder or disease other than dementia expected to interfere with the study,\n* Subjects unable to undergo MR scanning due to exclusion via UHCMC MR restrictions (e.g. certain implanted metallic or electronic devices),\n* History of adverse events related to a previous MR or PET/CT,\n* Pregnant women,\n* Minors.'}, 'identificationModule': {'nctId': 'NCT02343757', 'briefTitle': "Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid", 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': "Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid", 'orgStudyIdInfo': {'id': '12-12-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PET/CT vs. PET/MRI', 'description': 'Patients will be included if presenting with the clinical suspicious of AD, Mild Cognitive Impairment (MCI) or other cognitive impairment to be further determined.\n\nPatients will undergo two doubles scans in two steps with a maximum of 2 week between both: the first step will be one day double scan with FDG imaged by PET-CT and PET-MRI; and the second step will be one day double scan with 18F-florbetapir imaged by PET-CT and PET-MRI at a different timepoints as shown in figure 1.', 'interventionNames': ['Device: PET/MRI']}], 'interventions': [{'name': 'PET/MRI', 'type': 'DEVICE', 'armGroupLabels': ['PET/CT vs. PET/MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospital Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': "James K O'Donnell, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unviversity Hospitals Case Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}