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Clinical Trial Summary

Background: Multiple sclerosis (MS) is an autoimmune disease that has no cure. MRI is the main tool used in the study and treatment of people with MS. A tracer has been developed for cyclooxygenase-2 (COX-2), an enzyme found in the brain during inflammation. Researchers want to explore the role inflammation plays in MS and see if COX-2 is measurable in the brains of people with the disease. Objective: To see if COX-2 is detectable in the brains of individuals with MS. Eligibility: People ages 18 and older with MS who are otherwise healthy. Design: Participants will be screened with their medical history and a physical exam. They will have an EKG to check the electrical activity of the heart. Participants study involvement requires 2 to 3 visits and will last between 1 week and 4 months. Participants will have 2 PET scans of the brain. These might occur on the same day or on separate days. A small amount of a radioactive chemical will be injected through an intravenous catheter. A needle will be used to guide a thin plastic tube into an arm vein. The needle will be removed. Only the catheter will be left in the vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. They will wear a plastic mask molded to fit the head. The scan will last about 90 minutes. Participants will receive the medication celecoxib orally about 2 hours before the second scan. Participants will have blood tests. Participants must avoid certain medications a month prior to the PET scans.

Clinical Trial Description

Study Description: This study will examine whether cyclooxygenase 2 (COX-2) is elevated in the brain of individuals with Multiple Sclerosis (MS) Objectives: To determine whether COX-2 is detectable in the brains of individuals with MS Endpoints: Primary endpoint: Calculation of COX-2 density from [11C]MC1 PET scans, using baseline scans and scans after blockade with celecoxib Secondary endpoint: Comparison of [11C]MC1 specific uptake in different types of MS lesions (active, chronic active, inactive) and in normal white matter. Study Population: Sixteen (16) participants with MS will be recruited. Participants may be male or female. They must be >18 years old Phase: 2 Description of Sites/Facilities Enrolling Participants: This is a multisite protocol that will enroll patients from University of Maryland and have PET imaging performed at the NIH Clinical Center Description of Study Intervention: Participants will be intravenously injected with 20 mCi of [11C]MC1 twice, once at baseline and once after blockade by celecoxib Study Duration: 36 months Participant Duration: 2-3 days ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05062083
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact Maria D Ferraris Araneta, C.R.N.P.
Phone (301) 496-9423
Email [email protected]
Status Recruiting
Phase Phase 2
Start date October 20, 2021
Completion date April 11, 2025

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