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.
Investigation of Inflammation Using [18F]FZTA
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: PET scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The study will begin with whole-body PET dosimetry in healthy adult volunteers to determine the safety and safe radiation dose for a single PET scan in humans."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a new radioactive tracer called [18F]-FZTA with a PET scan to look for inflammation in the brain. A tracer helps show areas inside the body on a scan. The study is for healthy younger adults and adults with multiple sclerosis (MS).
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, of any sex or race.
- Able to give written consent to take part in the study.
- Healthy or diagnosed with MS using the revised 2017 McDonald rules for diagnosis.
Who can't join
- Allergic to [18F]-FZTA or any of its ingredients.
- Cannot safely have PET, CT, or MRI scans, such as because of certain electronic medical devices or trouble lying still for a long time.
- Have a severe fear of small, closed spaces.
- Are pregnant or breastfeeding.
- Are currently getting radiation treatment.
- Have a condition that the study doctor thinks could raise your risk, make study procedures hard to handle, or affect the data, such as kidney or liver failure or advanced cancer.
- Have had certain serious heart problems, a stroke, or a mini-stroke in the past 6 months, or have certain serious findings on the screening heart test (ECG). Examples include serious abnormal heart rhythms, a heart attack, blocked heart signals, unstable chest pain, or severe heart failure.
- Are taking part, or took part within 12 months before screening, in research using radioactive agents that would put your total yearly research radiation above U.S. legal limits.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
MO
- Washington University in St. Louis · St Louis, MO 63110Jayashree Rajamanickam · Study contact · 314-273-6140 · jayashree.r@wustl.eduKelley Jackson · Study contact · 314-362-3613 · kelleyj@wustl.eduTammie Benzinger, MD., PhD. · Principal investigatorMore trials in St Louis