NCT05062083

PET Imaging of Cyclooxygenase in Multiple Sclerosis

PET Imaging of Cyclooxygenases in Multiple Sclerosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: National Institute of Mental Health (NIMH) · NIH
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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. Tracers have been developed for cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), key enzymes that involved in neuroinflammation. Researchers want to explore the role inflammation plays in MS and see if COX-1 and COX-2 are measurable in the brains of people with the disease. Objective: To see if COX-1 and COX-2 are 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 3 to 5 visits and will last between 2 weeks and 4 months. Participants will have two positron emission tomography (PET) scans of the brain for each tracer. Scans of the same tracer 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 for each tracer. Participants will receive the medication ketoprofen or 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.

Detailed description

Study Description: This study will examine whether cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2) are elevated in the brain of individuals with Multiple Sclerosis (MS) Objectives: To determine whether COX-1 and COX-2 are detectable in the brains of individuals with MS. Endpoints: Primary endpoint: Calculation of COX-1 and COX-2 densities from \[11C\]PS13 and \[11C\]MC1 PET scans, respectively, using baseline scans and scans after blockade with ketoprofen and celecoxib, respectively. Secondary endpoint: 1) Comparison of \[11C\]PS13 and \[11C\]MC1 specific uptake in different types of MS lesions (active, chronic active, inactive) and in normal white matter. 2) Comparison of \[11C\]PS13 and \[11C\]MC1 specific uptake in the brain lesions of the same subjects

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	11C-MC1	Up to 20 mCi injected IV followed by PET scanning
DRUG	11C-PS13	Up to 20 mCi injected IV followed by PET Scanning
DRUG	Ketoprofen	Ketoprofen 75 mg orally once
DRUG	Celecoxib	celecoxib 600 mg orally once

Timeline

• Start date: 2022-06-07
• Primary completion: 2023-09-05
• Completion: 2024-01-30
• First posted: 2021-09-30
• Last updated: 2024-06-27
• Results posted: 2024-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study