Recruiting

\[18F\]-FZTA

Sponsor:

Washington University School of Medicine

Code:

NCT07115017

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

[18F] FZTA

Study Details

Brief summary:

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.

Conditions

Multiple Sclerosis

Study ID

NCT07115017

Start date

Aug 22, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy participants

Healthy participants will receive a single intravenous bolus injection of 7 ± 20% milliCurie (mCi) of the investigational radiotracer \[18F\]-FZTA. Participants will then undergo \[18F\]-FZTA PET scan.

Participants with Multiple Sclerosis

Participants with Multiple Sclerosis will receive a single intravenous bolus injection of 7 ± 20% milliCurie (mCi) of the investigational radiotracer \[18F\]-FZTA. Participants will then undergo a brain \[18F\]-FZTA PET scan

Interventions

[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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jayashree Rajamanickam

314-273-6140jayashree.r@wustl.edu

Kelley Jackson

314 362 3613kelleyj@wustl.edu

Locations

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Jayashree Rajamanickam

314-273-6140jayashree.r@wustl.edu

Kelley Jackson

314-362-3613kelleyj@wustl.edu

Principal Investigator:

Tammie Benzinger, MD., PhD.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 4, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-04.