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Search / Trial NCT07115017

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.

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Aug 4, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new type of brain scan that uses a special radioactive tracer called [18F]-FZTA to detect inflammation in the brain. Inflammation is a key feature of Multiple Sclerosis (MS), a condition that affects the nervous system. The study will include both healthy adults and people who have been diagnosed with MS, to see how well this new tracer works in showing areas of inflammation.

People aged 18 and older, of any gender or race, who can give written permission to take part may be eligible. This includes healthy volunteers as well as those diagnosed with MS. During the study, participants will undergo a PET scan, which is a painless imaging test that helps doctors see how the brain is functioning. The scan involves a small amount of radioactive tracer, but the study has specific safety rules to make sure it’s safe for participants, such as excluding those who are pregnant, have certain health conditions, or cannot lie still during the scan. If you qualify and choose to participate, you’ll help researchers learn more about detecting brain inflammation, which could improve how MS is diagnosed and monitored in the future.

Gender

ALL

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.

About Washington University School Of Medicine

Washington University School of Medicine is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research, education, and patient care. With a strong emphasis on translating scientific discoveries into practical applications, the institution conducts a diverse array of clinical trials aimed at improving treatment outcomes and enhancing the understanding of various medical conditions. Its collaborative environment fosters partnerships between researchers, clinicians, and community stakeholders, ensuring that the trials not only contribute to scientific knowledge but also address the pressing health needs of diverse populations.

Locations

Saint Louis, Missouri, United States

Patients applied

0 patients applied

Trial Officials

Tammie Benzinger, MD., PhD.

Principal Investigator

Washington University School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported