NCT07115017 · Washington University School of Medicine
This Study Involves a Positron Emission Tomography (PET) Scan Using a New Investigational Radioactive Tracer, [18F]-FZTA, to Detect Inflammation in the Brain. The Tracer Will be Tested in Healthy Younger Adults and Individuals With Multiple Sclerosis.
(FZTA Pilot)
What this study is about
This study involves a Positron Emission Tomography (PET) scan using a new experimental radioactive tracer, \[18F\]-FZTA, to detect inflammation in the brain. The tracer will be tested in healthy younger adults and individuals with Multiple Sclerosis.
View original scientific description
This study involves a Positron Emission Tomography (PET) scan using a new investigational radioactive tracer, \[18F\]-FZTA, to detect inflammation in the brain. The tracer will be tested in healthy younger adults and individuals with Multiple Sclerosis.
Interventions
DRUG
[18F] FZTA
Participants will receive a single intravenous bolus injection of 7 ± 20% milliCurie (mCi) of the investigational radiotracer \[18F\]-FZTA. A PET-certified medical professional will prepare and administer the \[18F\]-FZTA. Prior to the administration, the dosage will be assayed in a dose calibrator and diluted with 0.9% sodium chloride (normal saline) up to a total 20 mL syringe volume. Participants will receive a maximum intravenous bolus injection of 7+20% mCi of \[18F\]-FZTA followed by a 10 mL 0.9% sodium chloride (normal saline) flush.
Primary outcome measures
PET imaging studies of [18F]-FZTA in healthy control participants and participants with Multiple Sclerosis, and measuring the uptake of [18F]-FZTA tracer.
Time frame: Through study completion, an average of 2 years
To test the hypothesis that specific binding of \[18F\]-FZTA is elevated in participants with Multiple Sclerosis compared to healthy normal control participants.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- St Louis, Missouri
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 23, 2025 · Source of record for eligibility and locations