PET Imaging of Cyclooxygenase-2 in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

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.

      ...
    

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
    

Intervention name(s): 11C-MCI; 11C-PS13
Intervention type(s): Drug; Drug
Intervention description(s): Injected IV followed by PET scanning; Injected IV followed by PET Scanning
Intervention MeSH terms: 11C-PS13
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PET Imaging; Multiple Sclerosis; Neuroinflammation; Neurological Symptoms; Cyclooxygenases