MS multiple sclerosis
Conditions
Interventions
There will be two [11C]MeDAS PET scans performed to assess the feasibility and
test-retest variability of this myelin imaging method. The first [11C]MeDAS PET
scan will be performed with arterial bl
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion 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: * 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 endpoint is demyelinated lesion detection using [11C]MeDAS PET imaging with an optimal data analysis method for quantification of myelin binding. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints are: * A decreased patient burden by implementation of simplified analysis methods for quantitative [11C]MeDAS PET imaging of myelin without using arterial blood sampling. * Test-retest variability of the simplified analysis methods * The correlation between PET and MRI findings | — |
Countries
Netherlands
Outcome results
None listed