To investigate the impact of high field 3T MRI on the diagnostic criteria in MS in a large multicenter study population using multiple vendor MRI systems.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint of the study is MS lesion count: MR images from standard field
1.5T and high field 3T will be compared using total amount of lesions and
region specific amount of lesions.
Secondary outcome
Secondary endpoints of the study: Data on cortical lesions: a double-inversion
recovery (DIR) sequence is also included in the scanning protocol. This gray
matter specific sequence leads to higher detection of cortical lesions. There
is limited data on the quality of DIR at the various field strengths and
vendors.
Background summary
High field 3 Tesla (T) Multiple Resonance (MR) imaging might influence the
diagnosis of Multiple Sclerosis (MS), since it improves image resolution and
signal-to-noise ratio and hence, MS lesion detection. The only study that
followed a cohort of patients with a Clinically Isolated Syndrome (CIS)
suggestive of MS scanned at 1.5T and 3T, showed that 3T imaging has a
substantial influence on the classification according to MRI (Barkhof) criteria
but does not lead to an earlier diagnosis of MS. However, it is too premature
to take a definitive stand on the impact of higher field strength on diagnostic
MRI criteria by using data from this one, rather small (40 patients),
single-center and single-vendor cohort. The MAGNIMS (Magnetic Imaging in MS)
group set up a large multicenter, multivendor study. The current protocol only
applies to a part of this large MAGNIMS study, namely the patients that will be
scanned in the VUmc, Amsterdam.
Study objective
To investigate the impact of high field 3T MRI on the diagnostic criteria in MS
in a large multicenter study population using multiple vendor MRI systems.
Study design
Prospective study (being part of a larger multicenter study) comparing 1.5T MR
and 3T MR imaging of CIS patients.
Study burden and risks
Time burden for participants will be (at 3 time points) a 1.5T MRI scan (max.
60 minutes), a 3T MRI scan (max. 60 minutes) and a clinical examination (60
min). However, the 1.5T MRI scan is made in a clinical setting, which means no
extra burden for the CIS patients because this scan has to be made anyhow for
determining further strategy for the patient. In total the time burden will be
360 minutes for patients (3T scan, clinical examination at 3 timepoints) and
360 minutes for healthy control subjects (1.5T and 3T MR scan at 3 timepoints).
Risks of MRI at any field strength are low when standard procedures are
followed. No intervention takes place, so no serious side effects are expected.
There is a small chance that a subject will develop an allergic reaction to the
use of contrast agent. To minimise this chance, subjects are excluded from the
study if they had any allergic reactions to contrast enhancement in the past.
Furthermore, they will be observed closely by a specialised team during the
contrast administration and for some time after this.
De Boelelaan 1117
Amsterdam 1007 MB
NL
De Boelelaan 1117
Amsterdam 1007 MB
NL
Listed location countries
Age
Inclusion criteria
CIS suggestive of MS as defined by the International Panel
Age 18-59 years
Exclusion criteria
Vascular, malignant or other immunological diseases at present or in the past medical history;MRI related exclusion criteria:
- Claustrophobia
- Foreign non MR compatible metal objects in the body
- Foreign metal objects in or close to the head
- Allergic reaction to contrast administration in the past (only for patients)
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 | NL42131.029.12 |