Can a new PET tracer light up brain inflammation?

NCT ID NCT04517552

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial tests an experimental imaging tracer called [11C]-CS1P1, which is designed to attach to a protein involved in brain inflammation. The study will first check the tracer's safety and how it moves through the body in healthy volunteers, then compare its signals in people with multiple sclerosis and Alzheimer's disease against healthy controls. If the tracer works, it could offer a noninvasive way to see and measure inflammation in the living brain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an investigational PET imaging tracer called [11C]-CS1P1, given as a single injection
What this could lead to
If it works, this could lead to a new way to see and measure brain inflammation in living people, helping to diagnose and monitor diseases like Alzheimer's and multiple sclerosis.
What could go wrong
This is an early, first-in-human test, so the tracer may not bind as expected or may not clearly distinguish inflamed from healthy brain tissue. Safety and dosing are still being worked out.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Aim 1: Dosimetry/ Safety Group Ten healthy adult volunteers (5 males and 5 females) will be recruited and undergo whole-body PET/CT imaging for assessing the safety, dosimetry and metabolism of \[11C\]-CS1P1. Aim 2: Feasibility Cohort Aim 2A will consist of 24 adult volunteers that will be recruited and scanned to characterize \[11C\] CS1P1 uptake on PET scans of the brain and cervical lymph nodes, to assess for radiolabeled metabolites. Up to 20 participants who have completed Aim 2A will continue with the collection of test-retest and safety data, Aim 2B. Ten healthy controls age and gender-matched to 10 participants with MS will be invited to return for repeat imaging for test-retest reliability not less than 7 days after and not more than 12 months after baseline imaging.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female, any race; 2. Age ≥ 18 years; 3. Capable of providing written informed consent for volunteering to undergo research procedures. 4. Healthy volunteer or volunteer with a diagnosis of MS Exclusion Criteria: 1. Hypersensitivity to \[11C\]-CS1P1 or any of its excipients; 2. 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; 3. Severe claustrophobia 4. Women who are currently pregnant or breast-feeding; 5. Currently undergoing radiation therapy; 6. 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 collection of the data (e.g., renal or liver failure, advanced cancer); 7. Participants who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): unstable cardiac arrhythmias, myocardial infarction, unstable angina, stroke, transient ischemic attack or decompensated heart failure requiring hospitalization or Class III/IV heart failure; 8. Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment; 9. Must not participate in another drug or device study prior to the end of this study participation; 10. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.