Recruiting

Inflammation in MS

Sponsor:

Washington University School of Medicine

Code:

NCT06591429

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiotracer [11C]-CS1P1

Radiotracer [11C]-DPA-713

anti-CD20 MS treatment

Radiotracer [12F]-FDG

Study Details

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?

Conditions

Multiple Sclerosis

Study ID

NCT06591429

Start date

Jun 19, 2024

Status verified date

Dec, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants

Adults with MS taking part in this study.

Interventions

Radiotracer [11C]-CS1P1

Radiotracer used in PET/CT scans of the head and neck Dose range: 12-17 mCi

Radiotracer [11C]-DPA-713

Radiotracer used in PET/CT scans of the head and neck Dose range:15-20 mCi

anti-CD20 MS treatment

MS treatment taken indepenently after initial testing

Radiotracer [12F]-FDG

used in PET/CT scans of the head and neck Dose: 5-7 mCi

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Matthew Brier, MD, PhD

314-362-7666brierm@wustl.edu

Nicole Shelley, MA

314-730-0516nshelley@wustl.edu

Locations

Barnes Jewish Center for Clinical Imaging Research

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Matthew R Brier, MD, PhD

314-362-7666brierm@wustl.edu

Nicole E Shelley, MA

nshelley@wustl.edu

Principal Investigator:

Matthew R Brier, MD, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Apr 28, 2026

Last verified

Dec, 2025

Keywords

  • Multiple Sclerosis
  • Imaging
  • Inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-04-28.