The goal of the project is to validate the developed standardized atrophy measurement method at VU University Medical Centre in patients with MS. This is done by testing how well the measurements of atrophy agree between different scanners and…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantitative measures (median absolute difference, limits of agreement) of the
inter-scanner and intra-scanner variability of measurements of the 1-year
volume change of putamen, caudate nucleus, and the entire cerebrum using the
new, standardised method.
Secondary outcome
The same quantitative measures of reproducibility for other, widely used
methods to measure the volume change, specifically for the software Siena,
FIRST and FreeSurfer.
Background summary
In multiple sclerosis (MS), next to other pathophysiological effects, the brain
structures shrink. This shrinkage, which is also called atrophy depends
relatively strongly to the disease severity and the degree of cognitive
decline. It is unclear exactly which disease processes are responsible for this
decline. Therefore, there are ongoing studies to better understand the disease
as well as finding suitable drugs that can protect the brain against this
shrinkage. Therefore, an accurate measure of the rate at which brain structures
in MS patients shrink is demanding. With MRI (Magnetic Resonance Imaging)
measurement of the atrophy rate is in principle possible, but because the
results of these measurements differ between scanners and scanner settings, it
is currently not possible to compare different measurements with each other. In
VUmc, using a proof-of-concept grant from the NCA Brain Imaging Technology
program, a method has been developed to measure the rate of atrophy in the
brain of people with MS. In this method, the atrophy measurement is
standardized using "conventional" MRI images.
Study objective
The goal of the project is to validate the developed standardized atrophy
measurement method at VU University Medical Centre in patients with MS. This is
done by testing how well the measurements of atrophy agree between different
scanners and scanner settings, for three structures: putamen, caudate nucleus
and the cerebrum as a whole.
Study design
To evaluate the developed method, 25 MS patients and 10 healthy controls will
be scanned at baseline and after one year. Because this is the first
application of this new technology, a fairly extensive scan protocol is used
and all participants are scanned at three different MRI scanners. This is
necessary to examine the comparability between different MRI scanners. This
involves three different MRI scanners, all with a field strength of 3 Tesla,
but from different manufacturers: GE, Philips and Toshiba. These scanners are
available in the outpatient clinic of VUmc.
The scan protocol is repeated after one year and participation in this
follow-up is crucial to detect small changes that have taken place in a year.
All MR images will be produced without the administration of MRI contrast agent
and no invasive procedure or administration of drug is performed.
Standardization of the atrophy measurement will be followed by volunteers'
measurements based on additional MRI measurements performed on our standard
model (phantom). A patent application for this standardization model is
currently being prepared. Briefly, it involves imaging of home-built objects
(MRI phantoms) from which calibration information is obtained.
1. Scan and re-scan, scanner number one.
2. scan and re-scan, scanner number two.
3. scan and re-scan, scanner number three.
Each scan and re-scan takes about 40 minutes. We perform MRI scans at 3
different scanners. At any MRI, scanning takes up to 80 minutes, with a break
half way in which the subject briefly gets off the scanner. The scheduling of
the different MRI scans of one visit is done in consultation with participants
and based on availability of MRI for research. The scans of a single visit can
all be made on the same day or be spread over two or more days. The total
duration of the MRI scans for one visit (i.e. at all three MRI scanners) will
not exceed four hours. Because each scan also requires some preparation and
different MRI scanners may not always be available immediately, the total
duration of the visit may be longer.
Intra- and inter-scan reproducibility will be quantified by the median absolute
difference, as well as limits of agreement based on linear mixed model
analysis. These analyses will be conducted for the atrophy measured by both the
new method and by the automated methods such as SIENA, FIRST and Free Surfer.
Study burden and risks
No risks are associated with MRI acquisition and no immediate benefits are
expected for the patients. However, it is worth mentioning that any unexpected
findings, according to the *Toevalsbevindingen protocol* Hulst 2011, will be
reported to the treating specialist and the family doctor of the patients and
healthy controls, respectively.
De Boelelaan 1118 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
MS patient group:
1. Diagnosis of relapsing-remitting, secondary progressive, or primary progressive MS.
2. 18 to 70 years old.
3. Written informed consent;Healthy controls:
1. 18 to 70 years old.
2. Written informed consent
Exclusion criteria
1. Inability to undergo MRI, e.g. metal objects in or around the body, claustrophobia or inability to lie still in the scanner.
2. Pregnant
3. Any (relevant) neurological disease (for healthy subjects).
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 | NL55598.029.15 |