Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-02 @ 1:23 AM
Study NCT ID:
NCT06439992
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood for future use'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety of the new formulation of Fluselenamy PET Imaging in 8 healthy adult normal volunteers.', 'timeFrame': 'Through study completion, an average of 1 year', 'description': "Whole-body PET/CT images (skull vertex to proximal thighs) will be obtained in 8 healthy volunteers (4 males and 4 females) for up to a maximum of 4.5 hours immediately following intravenous (IV) injection of 10 mCi ± 20% of \\[18F\\]-Fluselenamyl (dosage range calculated from rodent dosimetry data extrapolated to humans).\n\nThe primary outcome measure is to quantify each organ's radiation exposure (rad/mCi)."}, {'measure': 'PET imaging of [18F]-Fluselenamyl in healthy normal control participants and participants with mild cognitive impairment.', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'To assess the sensitivity of \\[18F\\]-Fluselenamyl to image Amyloid beta in the setting of mild cognitive impairment, and conduct a comparative analysis of PET imaging data using \\[11C\\]-PIB imaging in the same participants.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging.', 'detailedDescription': "The investigators will first complete whole-body PET dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each human organ and determine the allowable dose for a human subject when receiving a single dose for a PET scan.\n\nSecond, imaging of the brain and neck will be completed in a wide range of ages of healthy adult normal control participants and participants with mild cognitive impairment, both male and females to characterize 18F-Fluselenamyl uptake in the brain, its binding to beta-amyloid plaques, and radiolabeled metabolite will be completed. Amyloid is a protein related to dementia of Alzheimer's disease. 11C-PIB PET imaging and MRI of the brain will also be completed in the same participants and the data will be compared with 18F-Fluselenmayl. 11C-PIB and 18F-Fluselenamyl both bind to beta-amyloid plaques.\n\nFinally, a comparison of the normal control participants to patients with Alzheimer's disease will be completed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Aim 1: Dosimetry group - 8 healthy adult normal volunteers (4 M, and 4 F) will undergo whole-body PET/CT imaging to assess the safety, dosimetry, and metabolism of 18F-FSA.\n\nAim 2: Proof of Concept group - 36 participants (18 healthy and 18 participants with mild cognitive impairment) will undergo 18F-FSA imaging of the brain and neck, 11C-PIB imaging of the brain and neck, MRI, and Cognitive testing.\n\nAim 3: Performance group- Aim 2 participants will be invited for additional imaging.\n\nAim 3A- 10 participants from Aim 2 will undergo repeat 18F-FSA imaging \\~ 1 month after baseline imaging\n\nAim 3B- 18 participants from Aim 2 will have a longitudinal follow-up visit \\~ 18 months after the initial study. They will undergo repeat 18F-FSA, 11C-PIB, MRI, and Cognitive testing.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or Female, any race\n* Age ≥ 18 years\n* Healthy volunteers or volunteers with Alzheimer's disease\n\nExclusion Criteria:\n\n* Has hypersensitivity to 18F-Fluselenamyl or any of its excipients ;\n* Has hypersensitivity to 11C-PIB or any of its excipients ;\n* Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;\n* Unwilling or unable to undergo PET scans tracer injections ;\n* Unwilling or unable to undergo MRI (Aim 2 and Aim 3)\n* Any condition that, in the Investigator's opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer);\n* Women who are currently pregnant or breast-feeding;\n* Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1."}, 'identificationModule': {'nctId': 'NCT06439992', 'briefTitle': 'Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Beta Amyloid PET Imaging for Alzheimer Disease: [18F]-Fluselenamyl (Alternative Vehicle) Comparison With [11C]-PIB (FSA-PIB AD)', 'orgStudyIdInfo': {'id': 'FSA-PIB AD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy participants', 'description': 'Healthy participants with normal cognition will be recruited and receive the following interventions:\n\nDrug: \\[18F\\]-Fluselenamyl. A dosage range of 10 mCi +/- 20% of Fluselenamyl will be injected by a PET-certified medical professional followed by 10 ml 0.9% sodium chloride (normal saline) flush.\n\nDrug: \\[11C\\]-Pittsburgh Compound (\\[11C\\]PIB) A dosage range between 6.0-20.0 mCi is planned. A PET-certified professional will prepare and administer the \\[11C\\]-PIB tracer. Participants will receive the PIB injection followed by a 10 ml 0.9% sodium chloride (normal saline) flush.', 'interventionNames': ['Drug: 18F-Fluselenamyl']}, {'label': 'Participants with mild cognitive impairment', 'description': 'Participants with mild cognitive impairment will be recruited and receive the following interventions:\n\nDrug: \\[18F\\]-Fluselenamyl. A dosage range of 10 mCi +/- 20% of Fluselenamyl will be injected by a PET-certified medical professional followed by 10 ml 0.9% sodium chloride (normal saline) flush.\n\nDrug: \\[11C\\]-Pittsburgh Compound (\\[11C\\]PIB) A dosage range between 6.0-20.0 mCi is planned. A PET-certified professional will prepare and administer the \\[11C\\]-PIB tracer. Participants will receive the PIB injection followed by a 10 ml 0.9% sodium chloride (normal saline) flush.', 'interventionNames': ['Drug: 18F-Fluselenamyl']}], 'interventions': [{'name': '18F-Fluselenamyl', 'type': 'DRUG', 'otherNames': ['18F-FSA'], 'description': 'Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer 18F-Fluselenamyl and will undergo an 18F-Fluselenamyl PET/CT scan of the head and neck.', 'armGroupLabels': ['Healthy participants', 'Participants with mild cognitive impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jayashree Rajamanickam', 'role': 'CONTACT', 'email': 'jayashree.r@wustl.edu', 'phone': '314-273-6140'}, {'name': 'Kelley Jackson', 'role': 'CONTACT', 'email': 'kelleyj@wustl.edu', 'phone': '314 362 3613'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Jayashree Rajamanickam', 'role': 'CONTACT', 'email': 'jayashree.r@wustl.edu', 'phone': '314 273 6140'}, {'name': 'Kelley Jackson', 'role': 'CONTACT', 'email': 'kelleyj@wustl.edu'}], 'overallOfficials': [{'name': 'Tammie Benzinger, MD., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology and Neurological Surgery', 'investigatorFullName': 'Tammie L. S. Benzinger, MD, PhD', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}