Imaging demyelination with [18F]3F4AP PET
Exploring the Utility of [18F]3F4AP for Demyelination Imaging
This test uses a PET tracer called [18F]3F4AP in adults with demyelinating conditions and in healthy volunteers to see how the tracer moves through the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06999434 on ClinicalTrials.gov |
What this trial studies
This Phase 1 imaging protocol administers the [18F]3F4AP tracer (with some participants also scanned with [18F]MK6240 or [11C]PIB) and performs PET scans to measure tracer distribution, clearance, and safety. Participants include healthy volunteers and people with demyelinating disorders such as mild cognitive impairment, Alzheimer's disease, multiple sclerosis, spinal cord injury, or spinal radiculopathy. The primary objective is to characterize pharmacokinetics and biodistribution of [18F]3F4AP in brain and spinal cord tissue while recording adverse events. Imaging is conducted at a single center with radiation exposure limits and monitoring built into the protocol.
Who should consider this trial
Good fit: Adults aged 18–89 who can give informed consent and who are either healthy volunteers or have demyelinating conditions (MCI, AD, MS, SCI, or spinal radiculopathy) and meet safety criteria are the intended participants.
Not a fit: People who are pregnant or breastfeeding, have unstable systemic illness, severe claustrophobia, bleeding disorders, excessive recent research radiation exposure, or are under 18 are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this tracer could provide a clearer, more specific way to detect and monitor demyelination across multiple conditions.
How similar studies have performed: PET-based approaches to image myelin and related pathology have been explored previously, but [18F]3F4AP is a novel tracer with limited human data so far.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: 1. Male and Female subjects must be ≥18 and \<90 years of age; 2. Able to understand and provide informed consent prior to study procedures 3. Must be in good health Exclusion: 1. Less than 18 years of age; 2. Pregnant or breastfeeding; 3. Any significant systemic illness or unstable medical condition; 4. Pre-existing medical conditions or claustrophobic reactions; 5. Research-related radiation exposure exceeds current PET Center guidelines (i.e. 50 mSv in the prior 12 months); 6. History of a bleeding disorder or are currently taking anticoagulants.
Where this trial is running
New Haven, Connecticut
- Yale University PET Center — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Georges El Fakhri, PhD, DABR — Yale University
- Study coordinator: Shannan Henry
- Email: shannan.henry@yale.edu
- Phone: +1 (203) 737-5278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.