To assess image quality of MR-STAT-generated synthetic image data sets in patients with neurological diseases (primary objective), and compare image quality of these synthetic images with those acquired individually according to standard clinical…
ID
Source
Brief title
Condition
- Other condition
- Central nervous system vascular disorders
Synonym
Health condition
Overige zenuwstelsel-aandoeningen: demyeliniserende aandoeningen (MS), neoplasmata en epilepsie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the image quality scores of the
MR-STAT-generated image data sets with regard to overall image quality, image
artifacts, and visualization of several predefined anatomical structures; these
scores will be compared with those of the standard MRI data sets.
Secondary outcome
The secondary study parameter will be the image quality of the
MR-STAT-generated image data sets compared with the standard MRI data sets,
assessed in a side-by-side fashion.
Background summary
A standard clinical MRI examination consists of several MRI sequences with
different image contrast weightings, that together take at least 20 minutes to
perform. This long acquisition time significantly reduces applicability of MRI
in the acute setting and in patients prone to motion during the examination,
including children. We have developed a new acquisition and post-processing
technique - MR-STAT - which is able to synthesize image data sets with various
clinically used contrast weightings, using only one 5-minute MRI sequence,
thereby substantially reducing the acquisition time.
Study objective
To assess image quality of MR-STAT-generated synthetic image data sets in
patients with neurological diseases (primary objective), and compare image
quality of these synthetic images with those acquired individually according to
standard clinical protocol (gold standard; secondary objective).
Study design
Single-center, cross-sectional study, conducted in the UMC Utrecht. MR-STAT
imaging will be performed on a 3.0 tesla (3T) MRI platform in 10 healthy
controls and 40 patients with varying neurological diseases, combined with
standard MRI sequences of the brain as gold standard. Three observers will
score all data while blinded to type of MRI technique. For the first objective,
MR-STAT image data sets will be scored on overall image quality, image
artifacts and visualization of major anatomical structures. For the second
objective, MR-STAT images will be assessed with the standard clinical MR images
in a side-to-side fashion, to compare image quality of the MR-STAT data sets
with gold standard.
Study burden and risks
Subjects will not benefit from this study. The risks associated with the study
correspond to the general risks associated with a clinical MRI examination,
such as temporary dizziness and claustrophobia. No contrast agent is needed.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a patient must meet the
following criteria:
• Age >= 18 years
• Diagnosed with one of the following neurological diseases: primary brain
tumor, epilepsy, MS or ischemic stroke
• Previous imaging findings characteristic of particular neurological disease
• Ability to lie supine in the MRI scanner for 45 minutesAlthough not an
inclusion criterion, care is taken to select those patients that are already
scheduled for a standard clinical follow-up MRI examination within the next 4
months, thereby limiting patient burden by providing the option to combine both
study- and clinical MRI examination on the same day.Inclusion criteria for
healthy volunteers are the following:
• Age >= 18 years
• No history of neurological diseases
Exclusion criteria
Patients will be excluded when meeting one of the following criteria:
• Atypical imaging findings not characteristic for the neurological
diagnosisExclusion criteria for the healthy volunteers are as follows:
• History of any neurological disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL69544.041.19 |
| OMON | NL-OMON26690 |