In 2009, a new combination of MRI sequences was published by Deoni et al. (2009) that promised the ability to measure the myelin water in vivo over the whole head in a clinically useful time. Referred to as mcDespot (multi-component driven…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Highly skilled radiologist from the VUmc will visually compare the standard
diagnostic scans (a T2 weighted fast spin echo and a 3D T1 weighted scan)
against the myelin water fraction images. All three types of scans will be
compared to determine any additional information the myelin water fraction
images may give. The healthy controls will provide a standard to judge the
impact of MS on the myelin water fraction images of the patients. Any
differences between lesions on the standard diagnostics images and the myelin
water images will be tabulated.
Secondary outcome
N/A
Background summary
As myelin plays a center role in MS pathology, direct and reliable information
on the state of the myelin in vivo would likely be valuable in diagnosis,
prognosis and treatment monitoring. Previously, myelin itself has been largely
invisible to MRI scans that were clinically practical. However, much of the in
vivo pathology we do see on MRI scans appears to be secondary to demyelination.
Being able to image myelin directly would allow the sub classification of MS
lesion based on the amount of demyelination. There have been many reports in
the literature of directly imaging myelin via myelin water, but those
techniques have been too time consuming. Thus, being able to image myelin over
the whole brain with useful resolution in a clinically acceptable scan time
should be a very valuable tool for monitoring in vivo pathology in MS.
Study objective
In 2009, a new combination of MRI sequences was published by Deoni et al.
(2009) that promised the ability to measure the myelin water in vivo over the
whole head in a clinically useful time. Referred to as mcDespot
(multi-component driven equilibrium single pulse observation of T1/2), the goal
of this pilot project is to provide an initial assessment of potential
usefulness of mcDespot in MS diagnosis, prognosis and treatment monitoring.
This pilot project*s protocol, in addition to mcDespot, will include a
conventional MRI diagnostic protocol for MS patients. mcDespot*s myelin images
will be compared against the images of the diagnosis protocol by VUmc*s
radiologists to see if mcDespot allows the sub classification of lesions based
on the state of the myelin.
Study design
The study will consist of scanning subjects for less than 1 hour each with a
set of MRI sequences. There will be 20 RRMS patients, 20 SPMS patients and 20
healthy controls in the cohort. The patients with a variety of in vivo MS
pathologies, based on previous MRI scans, will be included into the cohort. In
addition to the mcDespot sequences, the pilot studies protocol will include a
conventional MRI diagnostic protocol for MS patients.
Whether mcDespot provides new and potentially useful information for sub
classifying MS lesions will be assessed by comparing the images from the
standard MRI sequences against the mcDespot*s myelin images by highly
experienced radiologists at the VUmc.
If the pilot project determines that mcDespot appears to provides useful new
information on vivo MS pathology, additional studies will be conducted to
determine how relevant new sub classification are. These studies would likely
include nature history, diagnosis, prognosis and correlation with postmortem
pathology.
Study burden and risks
Volunteers will be asked to come to the hospital only once and only for a
single MRI scan. No contrast agent will be administered. Volunteers will be
asked to lie still in the scanner for a maximum duration of 1 hour. To reduce
the sound levels earplugs are provided. Volunteers can also choose for music
during the examination. During the scans some small breaks are planned to ask
for the volunteers well being and allow them to cough or relieve other
discomforts. MR scans are considered to have negligible risks. Before the
examination volunteers will be checked for metal objects in their body, risk of
claustrophobia or other excluding criteria.
De Boelelaan 1117
Amsterdam 1007 MB
NL
De Boelelaan 1117
Amsterdam 1007 MB
NL
Listed location countries
Age
Inclusion criteria
* Clinically definite MS (according to the subgroups)
* Age between 18 - 60 years of age (to exclude age related chance of other neurological disorders)
* EDSS < 5.5 (despite the fact that especially for SP patients this criterium lowers the number of available volunteers, the physical efforts necessary to complete the protocol may be hard for this group)
Exclusion criteria
* Clinically isolated syndrome
* Other neurological disorders
* Claustrophobia
* Foreign non MR compatible metal objects in the body
* Foreign metal objects in or close to the head
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 | NL33748.029.10 |