Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-01 @ 7:37 PM
Study NCT ID:
NCT07012993
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultralow Dose PET Imaging of 18F-Florbetapir, 18F-Flutemetamol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545186', 'term': 'florbetapir'}, {'id': 'C581552', 'term': 'flutemetamol'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-01', 'studyFirstSubmitDate': '2025-06-01', 'studyFirstSubmitQcDate': '2025-06-01', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signal-to-Noise Ratio (SNR)', 'timeFrame': 'Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.', 'description': 'Measurement of signal-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions.\n\nUnit of Measure: SNR (unitless, numeric ratio)'}, {'measure': 'Contrast-to-Noise Ratio (CNR)', 'timeFrame': 'Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.', 'description': 'Measurement of contrast-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions.\n\nUnit of Measure: CNR (unitless, numeric ratio)'}, {'measure': 'Coefficient of Variation (COV)', 'timeFrame': 'Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.', 'description': 'Measurement of the coefficient of variation in selected regions for evaluating image consistency across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions.\n\nUnit of Measure: Percentage (%)'}, {'measure': 'Spatial Resolution (Full Width at Half Maximum - FWHM)', 'timeFrame': 'Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.', 'description': 'Assessment of spatial resolution using full width at half maximum (FWHM) across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions.\n\nUnit of Measure: Millimeters (mm)'}, {'measure': 'Target-to-Background Ratio (TBR)', 'timeFrame': 'Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.', 'description': 'Assessment of target-to-background ratio for evaluating PSMA-expressing tissue contrast across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions.\n\nUnit of Measure: Ratio (unitless numeric ratio)'}, {'measure': 'Qualitative Image Quality Score (Likert Scale)', 'timeFrame': 'Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.', 'description': 'Independent qualitative evaluation of overall image quality, lesion detectability, image noise, and artifacts by nuclear medicine physicians, assessed using a 5-point Likert scale.\n\nUnit of Measure: Score on Likert Scale (1-5; 1 = worst, 5 = best)'}, {'measure': 'Inter-reader Agreement (Weighted Kappa Statistics)', 'timeFrame': 'Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.', 'description': 'Measurement of agreement among readers evaluating qualitative image quality scores, analyzed using weighted kappa statistics.\n\nUnit of Measure: Weighted kappa statistic (numeric value ranging from 0 to 1, 0 = no agreement, 1 = perfect agreement)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer', 'Alzheimer's Disease, Mild Cognitive Impairment, Other Forms of Dementia']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for Alzheimer's disease, mild cognitive impairment, other forms of dementia detection and monitoring. The main question it aims to answer is:\n\nCan the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard? Participants will be injected with a radioactive tracer called 18F-Florbetapir or 18F-Flutemetamol and be imaged on a new type of high-sensitivity PET scanner for up to 3 hours", 'detailedDescription': 'This research study aims to evaluate an investigational ultralow dose PET imaging technique for Alzheimer\'s disease, mild cognitive impairment, other forms of dementia detection and monitoring. "Investigational" means that the procedure or drug being studied is not yet approved by the FDA for the specific use being tested in this research. The PET imaging technique used in this study is considered investigational because it is being tested at an ultralow radiation dose that has not yet been approved for clinical use. The radiotracers are FDA-approved for detecting amyloid plaque that is found in Alzheimer\'s Disease at standard doses, but at a much higher dose than is being investigated in this protocol.\n\n18F-Florbetapir and 18F-Flutemetamol are often found to be taken up at higher levels in Alzheimer\'s disease, mild cognitive impairment, other forms of dementia. In this study, investigators will use a very small amount of this tracer (less than 1/20th of the standard dose) along with advanced PET imaging technology to see if it is possible to create clear images while using much less radiation. This study aims to develop a safer imaging technique that could potentially be used more frequently for screening and monitoring Alzheimer\'s disease, mild cognitive impairment, other forms of dementia.\n\nInvestigators will enroll individuals with and without Alzheimer\'s disease, mild cognitive impairment, other forms of dementia to evaluate how ultralow dose PET imaging detects radiotracer uptake in different types of tissue.\n\nApproximately 200 people will be enrolled in this study at the Nuclear Imaging Institute.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Ability to provide informed consent and comply with study procedures.\n3. For female participants:\n\n * Must not be pregnant or breastfeeding.\n * Negative pregnancy test required for women of childbearing potential.\n\nExclusion Criteria:\n\n1. Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total).\n2. More than four prior enrollments in this study.\n3. Participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the PET scan\n4. Pregnant or breastfeeding individuals (negative pregnancy test required)\n5. Inability to provide informed consent\n6. Any condition that, in the investigator's judgment, may compromise participant safety or study integrity."}, 'identificationModule': {'nctId': 'NCT07012993', 'briefTitle': 'Ultralow Dose PET Imaging of 18F-Florbetapir, 18F-Flutemetamol', 'organization': {'class': 'OTHER', 'fullName': 'Nuclear Imaging Institute'}, 'officialTitle': 'Evaluation of Ultralow Dose PET Imaging for Detecting Amyloid Tracer Uptake', 'orgStudyIdInfo': {'id': 'NII-0005-amyloid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ultralow dose imaging group', 'description': 'Participants will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours', 'interventionNames': ['Drug: 18F-Florbetapir or 18F-Flutemetamol']}], 'interventions': [{'name': '18F-Florbetapir or 18F-Flutemetamol', 'type': 'DRUG', 'otherNames': ['CT scan', 'PET scan', 'blood collection'], 'description': 'Participants will be injected with 18F-Florbetapir or 18F-Flutemetamol and imaged for up to 3 hours on a PET scanner', 'armGroupLabels': ['ultralow dose imaging group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Barbara Blanchfield', 'role': 'CONTACT', 'phone': '973-255-4955'}], 'facility': 'Nuclear Imaging Institute', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}], 'centralContacts': [{'name': 'Barbara Blanchfield', 'role': 'CONTACT', 'email': 'bblanchfield@nii.org', 'phone': '973-255-4955'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akiva Mintz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Executive Director', 'investigatorFullName': 'Akiva Mintz', 'investigatorAffiliation': 'Nuclear Imaging Institute'}}}}