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.

NCT07115017 | Recruiting DMC FDA Drug

• 1 other identifier: 202505042
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• PET imaging studies of [18F]-FZTA in healthy control participants and participants with Multiple Sclerosis, and measuring the uptake of [18F]-FZTA tracer.

  To test the hypothesis that specific binding of \[18F\]-FZTA is elevated in participants with Multiple Sclerosis compared to healthy normal control participants.

  Through study completion, an average of 2 years

Study Arms (2)

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.

Drug: [18F] FZTA

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

Drug: [18F] FZTA

Interventions

[18F] FZTA DRUG

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.

Healthy participants; Participants with Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Aim 1: Dosimetry/Safety group will consist of 10 healthy adult normal volunteers (5 males and 5 females) who will be recruited and undergo whole-body PET/CT imaging to assess the safety, dosimetry, and metabolism of \[F-18\]FZTA. All 10 participants will also undergo a short MRI without contrast. Aim 2: Proof of Concept/Healthy Cohort will consist of 15 healthy adult volunteers (Males and Females). Aim 3: Proof of Concept/MS cohort consists of 10 MS patients who are on stable therapy. Aim 4: Proof of Concept/MS cohort consists of newly diagnosed 20 RRMS patients who will be started on high-efficacy drugs. Aims 2,3, and 4 will undergo \[F-18\]FZTA PET imaging of the brain and neck, brain MRI, and an optional \[C-11\]CS1P1 and \[F-18\]FDG PET imaging.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for future research

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tammie Benzinger, MD., PhD.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayashree Rajamanickam

CONTACT

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

Kelley Jackson

CONTACT

314 362 3613; kelleyj@wustl.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hugh Monroe Wilson Professor of Radiology

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)