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New tracer could reveal hidden immune activity in brain diseases

NCT ID NCT05849467

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether a radioactive tracer called 89Zr-Df-crefmirlimab can help PET scans detect certain immune cells (CD8+ T cells) in the brain and spinal cord of people with multiple sclerosis (MS) or progressive multifocal leukoencephalopathy (PML). About 15 adults will receive the tracer and undergo PET and MRI scans over several weeks. The goal is to better understand how these diseases affect the central nervous system.

What this could mean

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

Active substance
89Zr-Df-crefmirlimab (a radioactive tracer that binds to CD8+ T cells)
What this could lead to
If successful, this could provide a new way to see where immune cells are active in the brain, helping researchers understand MS and PML better.
What could go wrong
This is a very small, early-phase pilot study with only 15 participants. The tracer may not work as expected, and results may not apply to everyone.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

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

Started

Oct 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Multiple Sclerosis Inclusion Criteria * Enrolled in the NINDS Natural History Study for MS (protocol 89-N-0045) * Able to understand, and willing to sign, a written, informed consent document. * Willing to comply with all study procedures and available for the duration of the study. * Male or female, aged \>=18. * Diagnosis of MS according to the 2017 revision of the McDonald diagnostic criteria48 (in the presence or absence of a clinical relapse). PML Inclusion Criteria * Enrolled in the NINDS Natural History Study for PML (protocol 13-N-0017) * Able to understand and willing to sign a written, informed consent document * Willing to comply with all study procedures and available for the duration of the study. * Male or female, aged \>=18. * Diagnosis of definite PML according to 2013 AAN Consensus Criteria49 or PML-IRIS based on clinical, radiological and laboratory evidence. Patients with Known or Suspected Neuroinflammatory Diseases and Evidence of Open BBB Inclusion Criteria -Clinical evaluation suggesting an inflammatory disorder of the central nervous system other than MS or PML. Other confirmed neuroinflammatory disorders may include -MOGAD, NMOSD, Behcet's syndrome, and neurosarcoidosis. Unconfirmed, though suspected cases of neuroinflammation may also be included. * Recent brain MRI (within 1 month) with gadolinium enhancement indicating open BBB. * Able to understand and willing to sign a written, informed consent document. * Willing to comply with all study procedures and available for the duration of the study. * Male or female, aged \>=18. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Pregnant or lactating. * Contraindications for MRI gadolinium contrast administration or 3T MRI. * History of, or current diagnosis with, concomitant medical or clinical conditions that would adversely affect participation in this study. * Weighs \> 350 lb. (158 kg; weight limit for the scanner table) or is unable to fit within the MRI or PET imaging gantry. * Severe claustrophobia unresponsive to oral anxiolytics. * Has an alkaline phosphatase level greater than 2x ULN (unless known to have non-liver related disorder) OR AST greater than 1.5 x ULN OR ALT greater than 1.5 x ULN. * Has a total bilirubin \>1.5X ULN, unless known to have elevated bilirubin due to nonliver related disorder or Gilbert s. * Creatinine clearance \< 60 mL/min as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) * For females of reproductive potential: inability to use highly effective contraception for at least one month prior to screening and during study participation.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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