Multiple SclerosisFZTA PilotNCT07115017
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.
An observational study of Multiple Sclerosis, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- [18F] FZTA
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2025to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Aim 1: Dosimetry/Safety group will consist of 10 healthy adult normal volunteers (5 males and 5 females) who will be recruited and undergo whole-body PET/CT imaging to assess the safety, dosimetry, and metabolism of [F-18]FZTA. All 10 participants will also undergo a short MRI without contrast. Aim 2: Proof of Concept/Healthy Cohort will consist of 15 healthy adult volunteers (Males and Females). Aim 3: Proof of Concept/MS cohort consists of 10 MS patients who are on stable therapy. Aim 4: Proof of Concept/MS cohort consists of newly diagnosed 20 RRMS patients who will be started on high-efficacy drugs. Aims 2,3, and 4 will undergo [F-18]FZTA PET imaging of the brain and neck, brain MRI, and an optional [C-11]CS1P1 and [F-18]FDG PET imaging.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Jayashree Rajamanickam, 314-273-6140, jayashree.r@wustl.edu
Kelley Jackson, 314-362-3613, kelleyj@wustl.edu
About this study
Official title: Investigation of Inflammation Using [18F]FZTA
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- [18F] FZTA
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F] FZTADrug
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 group | Role | What they receive |
|---|---|---|
| Healthy participants | Healthy participants will receive a single intravenous bolus injection of 7 ± 20% milliCurie (mCi) of the investigational radiotracer [18F]-FZTA. Participants will then undergo [18F]-FZTA PET scan. Receives: Drug: [18F] FZTA | |
| Participants with Multiple Sclerosis | Participants with Multiple Sclerosis will receive a single intravenous bolus injection of 7 ± 20% milliCurie (mCi) of the investigational radiotracer [18F]-FZTA. Participants will then undergo a brain [18F]-FZTA PET scan Receives: Drug: [18F] FZTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET imaging studies of [18F]-FZTA in healthy control participants and participants with Multiple Sclerosis, and measuring the uptake of [18F]-FZTA tracer.
To test the hypothesis that specific binding of [18F]-FZTA is elevated in participants with Multiple Sclerosis compared to healthy normal control participants.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start22 Aug 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine
- Investigators
- Tammie Benzinger, MD., PhD., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115017
- Sponsor's protocol ID
- FZTA Pilot
- Acronym
- FZTA Pilot
- Status last verified
- Dec 2025
- First submitted
- 4 Aug 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Inflammation Using [18F]FZTA
- ClinicalTrials.gov ID
- NCT07115017
- Acronym / sponsor ID
- FZTA Pilot / FZTA Pilot
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Drug: [18F] FZTAHealthy participants will receive a single intravenous bolus injection of 7 ± 20% milliCurie (mCi) of the investigational radiotracer [18F]-FZTA. Participants will then undergo [18F]-FZTA PET scan. |
| Participants with Multiple Sclerosis | – | Drug: [18F] FZTAParticipants with Multiple Sclerosis will receive a single intravenous bolus injection of 7 ± 20% milliCurie (mCi) of the investigational radiotracer [18F]-FZTA. Participants will then undergo a brain [18F]-FZTA PET scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Aim 1: Dosimetry/Safety group will consist of 10 healthy adult normal volunteers (5 males and 5 females) who will be recruited and undergo whole-body PET/CT imaging to assess the safety, dosimetry, and metabolism of [F-18]FZTA. All 10 participants will also undergo a short MRI without contrast. Aim 2: Proof of Concept/Healthy Cohort will consist of 15 healthy adult volunteers (Males and Females). Aim 3: Proof of Concept/MS cohort consists of 10 MS patients who are on stable therapy. Aim 4: Proof of Concept/MS cohort consists of newly diagnosed 20 RRMS patients who will be started on high-efficacy drugs. Aims 2,3, and 4 will undergo [F-18]FZTA PET imaging of the brain and neck, brain MRI, and an optional [C-11]CS1P1 and [F-18]FDG PET imaging.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F] FZTAParticipants 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. | Drug | Healthy participants, Participants with Multiple Sclerosis |
Primary outcome
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
To test the hypothesis that specific binding of [18F]-FZTA is elevated in participants with Multiple Sclerosis compared to healthy normal control participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
Related trials for Multiple Sclerosis
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Multiple Sclerosis Spasticity
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tammie Benzinger, MD., PhD. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayashree Rajamanickam (314-273-6140, jayashree.r@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.