Imaging demyelination with [18F]3F4AP PET

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.