Multiple Sclerosis, neurodegeneration, demyelination, demyelinisatie, neurodegeneratie
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 bloo
Sponsors
University Medical Center Groningen
Eligibility
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 primary objective of this study is to evaluate the ability of [11C]MeDAS PET to detect demyelinated MS lesions and to assess the best analysis method (pharmacokinetic model) for the quantification of [11C]MeDAS binding to myelin in humans. When this technique is made available for applications in humans, [11C]MeDAS PET can be used to improve diagnosis for e.g. multiple sclerosis, and as surrogate outcome measure in clinical trials that evaluate remyelinating agents. | — |
Secondary
| Measure | Time frame |
|---|---|
| · To investigate whether a reference region exists that would enable the use of simplified quantification methods (eliminating the use of arterial sampling) · To compare the reliability of these simplified quantification methods with the reliability of the “gold standard” procedure with arterial sampling. · To assess test-retest variability of the [11C]MeDAS PET when a simplified quantification method is used · To correlate [11C]MeDAS PET to MRI measurements (lesion detection) | — |
Outcome results
None listed