[11C]MeDAS PET: an imaging tool for quantitative assessment of changes in myelin density over time in multiple sclerosis

Phase 2

Completed

Conditions: MS
multiple sclerosis
10012303

Registration Number: NL-OMON49461

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is detection of changes in myelin density in MS<br /><br>lesions over time, indicative for myelin degradation or repair, as determined<br /><br>by [11C]MeDAS PET imaging. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints:<br /><br>• The correlation between [11C]MeDAS PET and clinical characteristics<br /><br>• The correlation between [11C]MeDAS PET results and specific MRI defined<br /><br>lesion types (black holes, normal appearing white matter, etc.)<br /><br>• The correlation between [11C]MeDAS PET results and putative MRI correlates of<br /><br>myelin density </p><br>