Using a radioactive tracer to detect immune cells in the brain for multiple sclerosis and PML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of an experimental radioactive tracer, known as a minibody, in detecting CD8+ T lymphocytes in the central nervous system of patients with multiple sclerosis (MS) and progressive multifocal leukoencephalopathy (PML) using positron emission tomography (PET) scans. Participants aged 18 and older will undergo a series of tests, including physical exams, blood tests, MRI scans, and possibly spinal taps over a period of 4 to 6 weeks. The primary goal is to assess the uptake of the tracer in different brain regions, while also monitoring safety and tolerability.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Daniel S Reich, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
• Study coordinator: Maria I Gaitan, M.D.
• Email: maria.gaitan@nih.gov
• Phone: (301) 496-1801

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.