PET scan with [18F]-FZTA to detect brain inflammation in people with MS and healthy younger adults
Investigation of Inflammation Using [18F]FZTA
This test tries a new PET tracer called [18F]-FZTA to see if it detects brain inflammation in adults with multiple sclerosis and in healthy younger adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07115017 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who can give informed consent and either have multiple sclerosis confirmed by the 2017 McDonald criteria or are healthy younger adults able to undergo PET/CT and MRI scans.
Not a fit: People who are pregnant or breastfeeding, have contraindications to PET/CT/MRI or implanted incompatible devices, severe claustrophobia, advanced organ failure, recent radiation therapy, or who cannot tolerate imaging procedures are unlikely to benefit.
Why it matters
Potential benefit: If successful, this tracer could allow clearer imaging of S1P1-related inflammation in the brain, improving detection or monitoring of inflammatory activity in people with MS.
How similar studies have performed: Other PET tracers for neuroinflammation (for example TSPO ligands) have been used in humans, but a tracer targeting S1P1 like [18F]-FZTA is novel and represents first-in-human testing with limited prior human data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
St Louis, Missouri
- 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
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.