An Open-label, Non-randomized Study to Evaluate the Feasibility of [18F]Florbetapir Positron Emission Tomography (PET) for Assessment of Demyelination in Patients With Relapsing Remitting Multiple Sclerosis
Overview
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Total Number of Lesions Detected by [18F]Florbetapir PET
Overview
Brief Summary
The purpose of this study is to evaluate the feasibility of [18F]Florbetapir positron emission tomography (PET) for assessment of demyelination in the patients with relapsing remitting multiple sclerosis.
Detailed Description
The underlying goal of this study is to assess the feasibility of [18F]Florbetapir as an imaging tool to detect demyelination in the brain of MS research participants and compare to similarly aged healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
[18F]Florbetapir PET imaging
[18F]Florbetapir and PET imaging
Intervention: [18F]Florbetapir PET imaging (Drug)
Outcomes
Primary Outcomes
Total Number of Lesions Detected by [18F]Florbetapir PET
Time Frame: 1 year
This study demonstrates the feasibility of\[18F\]Florbetapir PET for identifying demyelinating lesions in relapsing-remitting MS patients. It was expected that lesion size played a factor in identifying white matter lesions with those smaller than 5 mm less evident on PET. Using spherical volumes of interest the extent of reduction in the white matter uptake can be reliably quantified. This requires careful attention to techniques for sampling in both the lesions and white matter control regions for the subject.
Secondary Outcomes
No secondary outcomes reported