MS multiple sclerosis
Conditions
Interventions
The subjects will undergo two PET scans (with an interval of 9-12 months) with
the myelin tracer [11C]MeDAS, which binds to &beta
-sheet structures within intact
Myelin Basic Protein (MBP). In addition, the subjects will undergo two MRI
scans for comparison.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • At least 18 years of age • A diagnosis of primary or secondary progressive MS • Sign an Institutional Review Board (IRB) approved informed consent form prior to any study procedures • Subjects who, in the opinion of the principal investigator, can tolerate the [11C]MeDAS PET, MRI and blood sampling procedures
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Women who are pregnant or breast feeding • Clinical history of diminished renal and/or liver function • Inability to undergo MRI-scanning due to presence of materials in the body that can be magnetized and cannot be removed • Claustrophobia • Current clinically significant cerebrovascular disease • Blood donation within 6 months prior to the [11C]MeDAS PET scan • Current use of any investigational medications, or having participated in a trial with investigational medication within the last 30 days • In the opinion of the investigator, otherwise unsuitable for a study of this type
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is detection of changes in myelin density in MS lesions over time, indicative for myelin degradation or repair, as determined by [11C]MeDAS PET imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints: • The correlation between [11C]MeDAS PET and clinical characteristics • The correlation between [11C]MeDAS PET results and specific MRI defined lesion types (black holes, normal appearing white matter, etc.) • The correlation between [11C]MeDAS PET results and putative MRI correlates of myelin density | — |
Countries
Netherlands
Outcome results
None listed