NCT06591429Recruiting
Smoldering Inflammation in MS
Investigation of Smoldering Inflammation in Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 7 Sept 2024
- Start date
- 19 Jun 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Multiple sclerosis
- NCT number
- NCT06591429
What you commit to
- Study type: Observational
- Planned participants: 25
- From 19 Jun 2024 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Lab values
- eGFR less than 60 (for gadolinium)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barnes Jewish Center for Clinical Imaging Research Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.