Advanced MRI techniques and biomarkers to substitute gadolinium enhanced MRI for the detection of disease activity in multiple sclerosis.
- Conditions
- Multiple Sclerosis10007951
- Registration Number
- NL-OMON53657
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
To be eligible for this study, the participant must meet the following
criteria:
Diagnosed as CIS, RRMS, PPMS based on McDonald criteria (2017)
Adult (18-70 years old)
Signed informed consent
Separate inclusion criteria will be applied for the active and inactive
subgroup:
For the active subgroup:
one or more Gd-enhancing lesion on brain MRI or signs of clinical disease
activity
For the inactive subgroup:
no Gd enhancing lesion on brain MRI and no clinical signs of disease activity.
A potential participant will be excluded from the study based on the following
criteria:
contra-indications for MRI
Pregnancy
History of (psychiatric) disorder which causes the patient to be incompetent to
make a well-informed decision
Other concurrent neurological disease
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) Establishing differences in image characteristics of Gd enhancing and<br /><br>non-enhancing lesions on the advanced MRI sequences.<br /><br><br /><br>2) Establishing differences in image characteristics on the advanced MRI<br /><br>sequences between new lesions and previously present lesions.<br /><br><br /><br>3) Establishing differences between blood biomarker levels between participants<br /><br>with and without Gd enhancing lesions. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>