In this pilot study, we aim to investigate if increasing field strength beyond 7T will result in additional advantages in characterization of MS lesions in vivo and to identify its limitations and technical challenges. More specifically, firstly, if…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in white matter lesion volume/count, cortical lesion volume/count,
percentage of lesions with central veins, tolerability of the investigation,
between the field strengths, quantitative image quality parameters (signal- and
contrast-to- noise ratios).
Secondary outcome
.
Background summary
Multiple sclerosis (MS) is the most common demyelinating disease in the central
nervous system. Magnetic resonance imaging (MRI) has a prominent role in the
diagnosis and monitoring of the disease and is the most suitable instrument for
in vivo evaluation of MS pathology. In the past years there has been a vast
amount of ultra-high field MRI research in MS, showing the potential benefits
of its increased contrast- (CNR) and signal-to-noise ratio (SNR), allowing
higher spatial resolution. These benefits include higher sensitivity in lesion
detection including cortical grey matter lesions thanks to improved white/grey
matter contrast. Additionally, specificity is increased because of better
visualization of more MS specific pathological characteristics like the central
vein sign, due to the increased susceptibility effects at higher field
strengths combined with the aforementioned higher spatial resolution.
Study objective
In this pilot study, we aim to investigate if increasing field strength beyond
7T will result in additional advantages in characterization of MS lesions in
vivo and to identify its limitations and technical challenges. More
specifically, firstly, if this can potentially increase sensitivity for MS
white as well as grey matter lesions. Secondly, if MS specific pathology, like
the central vein sign and paramagnetic rims, can be better visualized at higher
compared to lower field strengths.
Study design
To scan 10 relapsing-remitting MS patients on a clinical field strength (3T) as
well as ultra-high-field strengths (7T and 9.4T) at two time points (baseline
and 6 months).
Study burden and risks
At baseline, patients will visit the MRI center to undergo a series of three
scans at each of the field strengths on the same day. Each scan will take 5 to
15 minutes preparation time and we strive for an image acquisition time of
around 30 minutes per scanner. This will be repeated after 6 months. Before the
second scanning session, patients will visit the outpatient clinic for a
regular follow up.
Dr H van der Hoffplein 1
Geleen 6162BG
NL
Dr H van der Hoffplein 1
Geleen 6162BG
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria: Relapsing remitting MS patients (according to the 2017
McDonald criteria) between age 18-65 years, who had a new brain MRI lesion in
the past 15 months. Choosing an upper limit of 65 years, limits the age-related
vascular white matter lesion burden on the brain scans.
Exclusion criteria
Patients who are unable to undergo MRI investigations due to (i) non-compatible
implanted material/devices or (ii) due to not being able to lie flat long
enough because of another medical condition, will be excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79074.096.22 |