RECRUITING

Smoldering Inflammation in MS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

Investigation of Smoldering Inflammation in Multiple Sclerosis

Quick Facts

Study Start:2024-06-19

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06591429

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Matthew Brier, MD, PhD

CONTACT

314-362-7666

brierm@wustl.edu

Nicole Shelley, MA

CONTACT

314-680-1435

shelleyn@wustl.edu

Study Locations (Sites)

Barnes Jewish Center for Clinical Imaging Research

St. Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-19

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-06-19

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

Multiple Sclerosis
Imaging
Inflammation

Additional Relevant MeSH Terms

Multiple Sclerosis