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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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.

Study Details

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.

Key Dates

Start date

Aug 22, 2025

Status verified

Dec 2025

Primary completion

Dec 31, 2028

Completion

Dec 31, 2029

Study Design

Enrollment

80 participants (estimated)

Arms

• Arm: 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.
• Arm: 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

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

• Jayashree Rajamanickam
  314-273-6140
  [email protected]
• Kelley Jackson
  314 362 3613
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

Related Studies

• Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
  PHASE1 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)
  PHASE1 · Recruiting · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Birmingham, Alabama
• Smoldering Inflammation in MS
  Recruiting · Washington University School of Medicine · St Louis, Missouri
• A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
  PHASE2 · Recruiting · ModernaTX, Inc. · Boston, Massachusetts