PET scan with [18F]-FZTA to detect brain inflammation in people with MS and healthy younger adults

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 observational first-in-human IND study uses PET imaging with an investigational tracer, [18F]-FZTA, targeting S1P1 to image brain inflammation. It begins with whole-body PET dosimetry in healthy volunteers to determine radiation safety and an appropriate single-scan dose. After dosimetry, healthy adult controls and people with MS undergo brain and neck PET imaging and a radiolabeled metabolite analysis to characterize tracer uptake. The study collects imaging and safety data to define biodistribution, radiation exposure, and feasibility of using [18F]-FZTA for neuroinflammation imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, any race
* Age ≥ 18 years
* Capable of providing written informed consent for volunteering to undergo research procedures.
* Healthy volunteer or volunteer with a diagnosis of MS established using the revised McDonald criteria (2017)

Exclusion Criteria:

* Hypersensitivity to \[18F\]FZTA or any of its excipients;
* Contraindications to PET, CT, or MRI (e.g., certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate.
* Severe claustrophobia
* Women who are currently pregnant or breastfeeding
* Currently undergoing radiation therapy
* Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection of the data (e.g., renal or liver failure, advanced cancer);
* Participants who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): clinically significant cardiac arrhythmias including atrial fibrillation with rapid ventricular response, myocardial infarction, high-grade heart block (type 2 or greater), unstable angina, stroke, transient ischemic attack or decompensated heart failure requiring hospitalization or Class III/IV heart failure;
* 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.

Where it's running

• Washington University in St. Louis
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Tammie Benzinger, MD., PhD. — Washington University School of Medicine
• Study coordinator: Jayashree Rajamanickam
• Email: jayashree.r@wustl.edu
• Phone: 314-273-6140

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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.