Actively Recruiting
Exploring the Utility of [18F]3F4AP for Demyelination Imaging
Led by Yale University · Updated on 2025-05-31
105
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the pharmacokinetics of [18F]3F4AP, a tracer used in PET scans, in healthy adults and people with demyelinating disorders such as mild cognitive impairment (MCI), Alzheimer's Disease, Multiple Sclerosis, Spinal Cord Injury, and Spinal Radiculopathy. This Phase 1 trial aims to better understand how this tracer distributes in the body and how it relates to disease markers like demyelination, tau, and amyloid burdens. Participants will undergo up to three PET scan sessions using three different tracers: [11C]PIB, [18F]MK6240, and [18F]3F4AP. The study groups include healthy controls and people diagnosed with the listed demyelinating conditions. Each group will have multiple PET scans to capture various imaging measures related to brain pathology and disease progression. During the study, participants will have brain imaging sessions to assess tracer distribution, brain atrophy, cerebrovascular burden, and white matter lesions. Researchers will evaluate multiple biomarkers and imaging outcomes over five years. The study involves no randomization or masking, and participants will be monitored for safety and imaging results throughout the trial.
CONDITIONS
Brief Title
Exploring the Utility of [18F]3F4AP for Demyelination Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18 to under 90 years
- Able to understand and provide informed consent before study procedures
- Must be in good health
You will not qualify if you...
- Under 18 years of age
- Pregnant or breastfeeding
- Any significant systemic illness or unstable medical condition
- Pre-existing medical conditions or claustrophobic reactions
- Research-related radiation exposure exceeds PET Center guidelines (over 50 mSv in prior 12 months)
- History of bleeding disorder or currently taking anticoagulants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies depending on scheduling of up to three PET scans
Participants undergo up to three PET scanning sessions using different imaging tracers to evaluate brain conditions.
Up to 3 visits for PET scans
Duration - 5 years
Participants are monitored over 5 years to assess imaging outcomes such as demyelination and brain pathology.
Periodic visits over 5 years for imaging and assessments
Trial Site Locations
Total: 1 location
1
Yale University PET Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
S
Shannan Henry
K
Kayla Cottiers
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
6
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