Smoldering Inflammation in MS
Investigation of Smoldering Inflammation in Multiple Sclerosis
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans, Spinal tap (lumbar puncture)
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Visits include 1) (pre-)screening and clinical, 2) baseline lumbar puncture, 3) baseline \[11C\]-DPA-713 PET/CT, 4) baseline \[11C\]-CS1P1 PET/CT, 5) baseline \[18F\]-FDG PET/MRI, 6) follow-up lumbar puncture, 7) follow-up \[11C\]-DPA-713 PET/CT, 8) follow-up \[11C\]-CS1P1 PET/CT, and 9) follow-up \[18F\]-FDG PET/MRI."
- "At each the baseline and follow-up time point, the lumbar puncture and each imaging session may occur in any order."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at ongoing inflammation in adults with relapsing-remitting multiple sclerosis (MS), a disease with flare-ups and periods of recovery. It compares inflammation in the nervous system with inflammation in cells and molecules, and asks why inflammation stays after treatment. It is an observational study, meaning researchers watch and collect information.
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?
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, of any sex or race.
- Able to give written consent to take part in research procedures.
- Have MS diagnosed by your referring doctor and confirmed by the study doctor.
- Have active MS, with at least one area of damage that lights up on a contrast scan within the past 6 months.
- Have not had MS treatment, except treatment for flare-ups, such as steroids or plasma exchange, a treatment that filters blood.
- Plan to start a highly effective MS medicine chosen by your referring doctor, such as ocrelizumab, natalizumab, or another medicine the study doctor considers similarly effective.
- Have blood tests within 3 months before joining, including blood cell counts and basic blood chemistry, with no major problems found by the study team.
Who can't join
- Have a gene change that causes low binding to TSPO, a protein used in study imaging.
- Have an allergy to any study imaging agent—[11C]-CS1P1, [11C]-DPA-713, or [18F]-FDG—or their ingredients.
- Cannot safely have PET, CT, or MRI scans, cannot lie still long enough, or have a severe fear of enclosed spaces.
- Have a kidney filtering score (eGFR) below 60, or diabetes that requires insulin.
- Are pregnant or breastfeeding, or are receiving radiation treatment.
- Cannot safely have a spinal tap, which collects fluid from the lower back. This includes a blood-clotting disorder, a mass inside the skull, or use of certain blood-thinning medicines, except aspirin 81 mg.
- Have another condition the study team thinks could make participation unsafe, make procedures hard to tolerate, or affect data collection, such as kidney or liver failure or advanced cancer.
- Are in, or were in during the past 12 months, research using radioactive agents that would bring your total research radiation exposure above 5 rem in any year.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
MO
- Barnes Jewish Center for Clinical Imaging Research · St Louis, MO 63110Matthew R Brier, MD, PhD · Study contact · 314-362-7666 · brierm@wustl.eduNicole E Shelley, MA · Study contact · nshelley@wustl.eduMatthew R Brier, MD, PhD · Principal investigatorMore trials in St Louis