What this study is
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.
What's being tested
- [18F] FZTA
Intervention · 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
- Official title
- Investigation of Inflammation Using [18F]FZTA
- Sponsor
- Washington University School of Medicine
- Conditions
- Multiple Sclerosis
- Enrolling
- 80 people
- Starts
- 2025-08-22
- Est. completion
- 2029-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openWashington University in St. Louis
St Louis, Missouri, United States
- Jayashree Rajamanickam · Contact314-273-6140jayashree.r@wustl.edu
- Kelley Jackson · Contact314-362-3613kelleyj@wustl.edu
- Tammie Benzinger, MD., PhD. · Principal investigator
Recruiting
Study team
Sponsor
Washington University School of Medicine
Study ID FZTA Pilot
Principal investigator
Tammie Benzinger, MD., PhD.
Washington University School of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.