Smoldering Inflammation in MS
Recruiting
- Conditions
- Registration Number
- NCT06591429
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
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?
- Detailed Description
The purpose of this study is to combine multi-tracer PET and high-resolution CSF analysis to understand the inflammatory landscape of MS and to identify components of inflammation which do not resolve with high-efficacy DMT and are hypothesized to drive disability accumulation via smoldering inflammation. Identification of components of the pathologic cascad...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- 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.
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Exclusion Criteria
- Presence of a "low binding" polymorphism for TSPO
- Hypersensitivity to [11C]-CS1P1, [11C]-DPA-713, [18F]-FDG, or any of their excipients;
- 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;
- eGFR less than 60 (for gadolinium)
- Severe claustrophobia
- Women who are currently pregnant or breast-feeding;
- Currently undergoing radiation therapy
- 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);
- 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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Volume of Distribution (Vt) of DPA-713 and CS1P1 and Cerebral metabolic rate of glucose (CMRglc) in white matter lesions and normal appearing white matter before and after treatment. 1 year Changes in scRNAseq measures of inflammatory cell types in the CSF before and after treatment 1 year
- Secondary Outcome Measures
Name Time Method Correlation between changes in Vt or CMRglc compared to changes in cell type numbers from scRNAseq 1 year