NCT06591429 · Washington University School of Medicine
Smoldering Inflammation in MS
What this study is about
The goal of this observational study is to learn about inflammation in those with relapsing remitting Multiple Sclerosis (MS).
View original scientific description
The goal of this observational study is to learn about inflammation in those with relapsing remitting Multiple Sclerosis (MS).
Interventions
RADIATION
Radiotracer [11C]-CS1P1
Radiotracer used in PET/CT scans of the head and neck Dose range: 12-17 mCi
RADIATION
Radiotracer [11C]-DPA-713
Radiotracer used in PET/CT scans of the head and neck Dose range:15-20 mCi
DRUG
anti-CD20 MS treatment
MS treatment taken indepenently after initial testing
RADIATION
Radiotracer [12F]-FDG
used in PET/CT scans of the head and neck Dose: 5-7 mCi
Primary outcome measures
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.
Time frame: 1 year
Changes in scRNAseq measures of inflammatory cell types in the CSF before and after treatment
Time frame: 1 year
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
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
Where
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 28, 2026 · Source of record for eligibility and locations