Multiple Sclerosis
Conditions
Brief summary
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 mL 0.9% sodium chloride (normal saline) flush.
Sponsors
Washington University School of Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET imaging studies of [18F]-FZTA in healthy control participants and participants with Multiple Sclerosis, and measuring the uptake of [18F]-FZTA tracer. | Through study completion, an average of 2 years | To test the hypothesis that specific binding of \[18F\]-FZTA is elevated in participants with Multiple Sclerosis compared to healthy normal control participants. |
Countries
United States
Contacts
CONTACTJayashree Rajamanickam
CONTACTKelley Jackson
PRINCIPAL_INVESTIGATORTammie Benzinger, MD., PhD.
Washington University School of Medicine
Outcome results
None listed