Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 6:54 PM
Study NCT ID:
NCT06999434
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2025-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Utility of [18F]3F4AP for Demyelination Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C475519', 'term': "2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-05-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-15', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tracers volume of distribution (VT)', 'timeFrame': '5 years', 'description': 'PET images measured with \\[ 18F\\]3F4AP will quantify demyelination, those obtained with \\[18F\\]MK6240 will quantify tau burden and those obtained with \\[11C\\]PiB will reflect amyloid burden.\n\nPET images acquired with \\[18F\\]3F4AP, \\[18F\\]MK6240 and \\[11C\\]PiB, will measure the tracers volume of distribution (VT).'}, {'measure': 'Distribution volume ratio (DVR)', 'timeFrame': '5 years', 'description': 'PET images acquired with \\[18F\\]3F4AP, \\[18F\\]MK6240 and \\[11C\\]PiB, will measure the tracers distribution volume ratio (DVR).'}, {'measure': 'Binding potential (BPND)', 'timeFrame': '5 years', 'description': 'PET images acquired with \\[18F\\]3F4AP, \\[18F\\]MK6240 and \\[11C\\]PiB, will measure the tracers binding potential (BPND).'}, {'measure': 'Demyelination', 'timeFrame': '5 years', 'description': '\\[18F\\]3F4AP will be used to measure demyelination. On the MR images, after co-registration and alignment, signal from pre- and post-contrast T1-weighted images, T2-weighted image, ratio between T1- and T2-weighted images (T1/T2) will be calculated to assess demyelination and white matter lesion (WML) on MR sequences.'}, {'measure': 'Tau burden', 'timeFrame': '5 years', 'description': '\\[18F\\]MK6240 will be used to measure Tau burden.'}, {'measure': 'Amyloid burden', 'timeFrame': '5 years', 'description': '\\[11C\\]PiB will reflect amyloid burden.'}, {'measure': 'Tracer rate constant', 'timeFrame': '5 years', 'description': 'The tracer rate constant for transfer from arterial plasma to tissue K1 and relative delivery R1 will also be estimated using tracer kineticmodeling technique, to provide measures of cerebral perfusion or CBF.'}, {'measure': 'Associations between imaging modalities and biomarkers.', 'timeFrame': '5 years', 'description': 'The Pearson correlation coefficient r will be used to assess the strength of the linear correlations between outcome measures. A P value of 0.05 or less will be considered statistically significant.'}], 'secondaryOutcomes': [{'measure': 'Measure of brain atrophy', 'timeFrame': '5 years', 'description': 'T1 images segmented and parcellated using FreeSurfer will be used to calculate cortical volumes, including the total cortical volume but also the hippocampal volume and will serve as proxies for neocortical and allocortical atrophy.'}, {'measure': 'Measure of cerebrovascular burden', 'timeFrame': '5 years', 'description': 'volume of White matter hyperintensities (WMH) on T1 images or T2 images'}, {'measure': 'Measure of White matter lesions (WML)', 'timeFrame': '5 years', 'description': 'The total WML load score will be calculated as the sum of the frequency of lesions multiplied by their volume.'}, {'measure': 'MR/MRSI images', 'timeFrame': '5 years', 'description': 'Evaluated to determine the effect of pulse sequence parameters and/or hardware configuration on image quality. The images acquired with different pulse sequence parameters or MR hardware configurations will be compared. Comparison of the MR images entails comparing the result of specific image quality measures such as signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) as well as the level of image artifacts'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['3F4AP', 'Demyelinating Disorders', 'MS', 'SCI', 'AD'], 'conditions': ['Demyelinating Disorders', 'MCI', "Alzheimer's Disease (AD)", 'MS (Multiple Sclerosis)', 'SCI - Spinal Cord Injury', 'Spinal Radiculopathy']}, 'descriptionModule': {'briefSummary': "The overall objective is to obtain an assessment of the pharmacokinetics of \\[18F\\]3F4AP in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (MCI), Alzheimer's Disease (AD), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and Spinal radiculopathy (SR)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion:\n\n1. Male and Female subjects must be ≥18 and \\<90 years of age;\n2. Able to understand and provide informed consent prior to study procedures\n3. Must be in good health\n\nExclusion:\n\n1. Less than 18 years of age;\n2. Pregnant or breastfeeding;\n3. Any significant systemic illness or unstable medical condition;\n4. Pre-existing medical conditions or claustrophobic reactions;\n5. Research-related radiation exposure exceeds current PET Center guidelines (i.e. 50 mSv in the prior 12 months);\n6. History of a bleeding disorder or are currently taking anticoagulants.'}, 'identificationModule': {'nctId': 'NCT06999434', 'briefTitle': 'Exploring the Utility of [18F]3F4AP for Demyelination Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Exploring the Utility of [18F]3F4AP for Demyelination Imaging', 'orgStudyIdInfo': {'id': '2000039282'}, 'secondaryIdInfos': [{'id': '7P41EB022544-08', 'link': 'https://reporter.nih.gov/quickSearch/7P41EB022544-08', 'type': 'NIH'}, {'id': '7R01EB033582-03', 'link': 'https://reporter.nih.gov/quickSearch/7R01EB033582-03', 'type': 'NIH'}, {'id': '7R01AG076153-03', 'link': 'https://reporter.nih.gov/quickSearch/7R01AG076153-03', 'type': 'NIH'}, {'id': '1R01AG085561-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG085561-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Control', 'description': 'n = 30 - up to three PET scanning sessions.', 'interventionNames': ['Drug: [ 18F]3F4AP', 'Drug: [18F]MK6240', 'Drug: [11C]PIB']}, {'type': 'EXPERIMENTAL', 'label': "Alzheimer's Disease (AD)", 'description': 'n = 15 - up to three PET scanning sessions.', 'interventionNames': ['Drug: [ 18F]3F4AP', 'Drug: [18F]MK6240', 'Drug: [11C]PIB']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Cognitive Impairment (MCI)', 'description': 'n = 15 - up to three PET scanning sessions.', 'interventionNames': ['Drug: [ 18F]3F4AP', 'Drug: [18F]MK6240', 'Drug: [11C]PIB']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Sclerosis (MS)', 'description': 'n = 15 - up to three PET scanning sessions.', 'interventionNames': ['Drug: [ 18F]3F4AP', 'Drug: [18F]MK6240', 'Drug: [11C]PIB']}, {'type': 'EXPERIMENTAL', 'label': 'Spinal Cord Injury (SCI)', 'description': 'n = 15 - up to three PET scanning sessions.', 'interventionNames': ['Drug: [ 18F]3F4AP', 'Drug: [18F]MK6240', 'Drug: [11C]PIB']}, {'type': 'EXPERIMENTAL', 'label': 'Spinal radiculopathy (SR)', 'description': 'n = 15 - up to three PET scanning sessions.', 'interventionNames': ['Drug: [ 18F]3F4AP', 'Drug: [18F]MK6240', 'Drug: [11C]PIB']}], 'interventions': [{'name': '[ 18F]3F4AP', 'type': 'DRUG', 'description': 'PET Scan #3', 'armGroupLabels': ["Alzheimer's Disease (AD)", 'Healthy Control', 'Mild Cognitive Impairment (MCI)', 'Multiple Sclerosis (MS)', 'Spinal Cord Injury (SCI)', 'Spinal radiculopathy (SR)']}, {'name': '[18F]MK6240', 'type': 'DRUG', 'description': 'PET Scan #2', 'armGroupLabels': ["Alzheimer's Disease (AD)", 'Healthy Control', 'Mild Cognitive Impairment (MCI)', 'Multiple Sclerosis (MS)', 'Spinal Cord Injury (SCI)', 'Spinal radiculopathy (SR)']}, {'name': '[11C]PIB', 'type': 'DRUG', 'description': 'PET Scan #1', 'armGroupLabels': ["Alzheimer's Disease (AD)", 'Healthy Control', 'Mild Cognitive Impairment (MCI)', 'Multiple Sclerosis (MS)', 'Spinal Cord Injury (SCI)', 'Spinal radiculopathy (SR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale University PET Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Shannan Henry', 'role': 'CONTACT', 'email': 'shannan.henry@yale.edu', 'phone': '+1 (203) 737-5278'}, {'name': 'Kayla Cottiers', 'role': 'CONTACT', 'email': 'kayla.cottiers@yale.edu', 'phone': '203-737-7496'}], 'overallOfficials': [{'name': 'Georges El Fakhri, PhD, DABR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Biomedical Imaging and Bioengineering (NIBIB)', 'class': 'NIH'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology and Biomedical Imaging and of Biomedical Informatics & Data Science', 'investigatorFullName': 'Georges El Fakhri', 'investigatorAffiliation': 'Yale University'}}}}