1) To determine whether advanced MRI techniques can detect active inflammatory Gd enhancing lesions. 2) To determine whether blood biomarkers are associated with the presence of enhancing brain lesions in MS. 3) To determine whether advanced MRI…
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Establishing differences in image characteristics of Gd enhancing and
non-enhancing lesions on the advanced MRI sequences.
2) Establishing differences in image characteristics on the advanced MRI
sequences between new lesions and previously present lesions.
3) Establishing differences between blood biomarker levels between participants
with and without Gd enhancing lesions.
Secondary outcome
Not applicable.
Background summary
Multiple sclerosis (MS) is characterized by active inflammatory lesions in the
brain and spinal cord. These active inflammatory lesions are imperative for
diagnostic and treatment purposes and can be detected by conventional MR
imaging with the intravenous injection of Gadolinium (Gd) chelates. Several
studies have made disconcerting reports of intracerebral deposition of Gd with
repeated intravenous administration. Although the long-term consequences of
this intracerebral deposition of Gd have not been identified, these findings
have prompted the medical community to limit the use of IV Gd, as much as
possible. This project aims to circumvent the use of intravenous Gd by
studying alternative advanced MRI techniques and blood biomarkers to detect
active inflammatory Gd enhancing lesions of the brain in MS.
Study objective
1) To determine whether advanced MRI techniques can detect active inflammatory
Gd enhancing lesions.
2) To determine whether blood biomarkers are associated with the presence of
enhancing brain lesions in MS.
3) To determine whether advanced MRI techniques can distinguish between new
recently active and older inactive lesions detected on high-resolution
isotropic serial FLAIR images.
Study design
Prospective cross-sectional mono-center study.
Study burden and risks
This study will include a single study visit. Besides the burden of an extra
visit to the hospital, the patients will undergo blood sampling and a brain MRI
scan that is approximately 23 minutes longer than a routine clinical MRI of
approximately 25 minutes. There will be no direct benefit for the participating
patients. The group benefit will be the reduction of intravenous Gd injection
and the associated long-term accumulation of Gd in body tissues for patients
with MS. The blood sampling and brain MRI scan with intravenous gadolinium
administration are of low risk, evidenced by extensive experience in daily
clinical routine.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
To be eligible for this study, the participant must meet the following
criteria:
Diagnosed as CIS, RRMS, PPMS based on McDonald criteria (2017)
Adult (18-70 years old)
Signed informed consent
Separate inclusion criteria will be applied for the active and inactive
subgroup:
For the active subgroup:
one or more Gd-enhancing lesion on brain MRI or signs of clinical disease
activity
For the inactive subgroup:
no Gd enhancing lesion on brain MRI and no clinical signs of disease activity.
Exclusion criteria
A potential participant will be excluded from the study based on the following
criteria:
contra-indications for MRI
Pregnancy
History of (psychiatric) disorder which causes the patient to be incompetent to
make a well-informed decision
Other concurrent neurological disease
Design
Recruitment
Medical products/devices used
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 | NL80209.018.23 |