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Smoldering Inflammation in MS

Key facts

Where
St Louis, United StatesSee the site

Where in United States

  • Barnes Jewish Center for Clinical Imaging ResearchSt Louis, United StatesTaking people

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  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Washington University School of Medicine
Trial code
NCT06591429
Record updated
28 April 2026
Original description
The goal of this observational study is to learn about inflammation in those with relapsing remitting Multiple Sclerosis (MS). The main questions it aims to answer are:Read full original descriptionShow less

Investigation of Smoldering Inflammation in Multiple Sclerosis

The goal of this observational study is to learn about inflammation in those with relapsing remitting Multiple Sclerosis (MS). The main questions it aims to answer are:

* How does abnormal neural inflammation compare to cellular and molecular inflammation in MS? * Once treated, why does abnormal inflammation persist?

Inclusion: Male or female, any race; Age ≥ 18 years; Capable of providing written informed consent for volunteering to undergo research procedures; Diagnosis of MS as established by the referring physician and confirmed by the Sponsor-Investigator. Only patients with active disease, defined as at least 1 enhancing lesion present in the preceding 6 months, will be enrolled; Treatment naïve except for relapse-related treatments such as corticosteroids or plasmapheresis,; Planned initiation, at the discretion of the referring physician, of a high efficacy DMT. High efficacy DMT will be defined to include ocrelizumab, natalizumab, or any MS treatment in the opinion of the Sponsor-Investigator to have similar efficacy as the named treatments; Clinical labs, including at least a CBC and BMP, without significant abnormality as determined by the Sponsor-Investigator or designee, within the 3 months prior to enrollment.

Exclusion: Currently undergoing radiation therapy; 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 5 rem; Hypersensitivity to [11C]-CS1P1, [11C]-DPA-713, [18F]-FDG, or any of their excipients; Insulin dependent diabetes; Contraindication to lumbar puncture (LP), including use of antiplatelet therapy (other than aspirin 81mg), therapeutic anticoagulation, or space occupying intracranial mass. History of a coagulopathy is also exclusionary; 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); eGFR less than 60 (for gadolinium); Presence of a low binding polymorphism for TSPO; 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 breast-feeding.

ClinicalTrials.gov NCT06591429