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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [18F] FZTA.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigation of Inflammation Using [18F]FZTA
Overview
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.
Detailed description
The primary objective of this initial IND study is to evaluate the safety of \[18F\]-FZTA for PET imaging of S1P1 expression. 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. Following this, brain and neck imaging will be conducted in both healthy adult control participants and individuals with multiple sclerosis (both male and female) to characterize \[18F\]-FZTA uptake in the brain. An analysis of the radiolabeled metabolite will also be completed as part of this study.
Interventions
- Drug [18F] FZTA
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
Primary outcome measures
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Washington University in St. Louis — St Louis
Identifiers
NCT: NCT07115017 · FZTA Pilot