[11C]MeDAS PET: a non-invasive imaging tool for quantitative assessment of myelin loss in multiple sclerosis
- Conditions
- MSmultiple sclerosis10012303
- Registration Number
- NL-OMON46348
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
* 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
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoint is demyelinated lesion detection using [11C]MeDAS PET<br /><br>imaging with an optimal data analysis method for quantification of myelin<br /><br>binding. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study endpoints are:<br /><br>* A decreased patient burden by implementation of simplified analysis methods<br /><br>for quantitative [11C]MeDAS PET imaging of myelin without using arterial blood<br /><br>sampling.<br /><br>* Test-retest variability of the simplified analysis methods<br /><br>* The correlation between PET and MRI findings</p><br>