Primary Objective: To realize a clinically applicable quantification of BBB permeability using DCE-MRI by determining the reproducibility of the DCE-MRI methodSecondary Objective: To achieve the shortest scan duration without compromising the…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are: Quantitative pharmacokinetic parameter
values: Ki, linked to the BBB permeability, and vb linked to the blood volume.
Primary endpoint is to assess the reproducibiliy of the quantified
pharmacokinetic parameters
Secondary outcome
The secondary study parameters are: Quantitative parameters: mean Ki and
standard error in the mean Ki determined as a function of scan duration. Mean
Ki is taken over all ROI*s or all subjects. The standard error is taken as a
measure for the reliability.
Secondary endpoint is to assess the optimal scan duration without compromizing
the reliability of the quantification of the pharmacokinetic parameters.
Background summary
Cerebral small vessel disease (cSVD) encompasses all pathological processes
that affect the small vessels of the brain. On brain-MRI cSVD is characterized
by structural brain abnormalities such as white matter lesions (WMLs).
Clinically, cSVD is related to acute syndromes as lacunar stroke but also to
more chronic health problems such as cognitive decline.
Recent literature suggests that a disrupted blood brain barrier (BBB), leading
to elevated BBB permeability, may play a pivotal role in the aetiology of cSVD
and lacunar stroke. The BBB is a complex system of neuronal, glial and vascular
cells which main function is to shield the brain from toxic components and
regulate the homeostasis. Elucidating the role of the BBB may have far reaching
consequences for the treatment of cSVD patients and the reduction of recurrence
rate of the disease. This could lead to a better quality of life among cSVD
patients and reduce the economic burden on society.
Currently the exact contribution and extent of a possibly defective BBB in cSVD
remains largely unclear, due to the lack of a reliable method to accurately
quantify the BBB permeability in cSVD patients. As a result, the current
treatment consists of treating the cardiovascular risk factors, often with poor
results.
Quantification of the BBB permeability provides an objective measure of the
integrity of the BBB and as such aids the study of the role of the BBB. The aim
of this study is to realize a clinically applicable MRI-method to quantify the
BBB permeability. Moreover, the method can be used to study the involvement of
BBB disruption in other neuropathologies including Alzheimer*s disease,
vascular dementia, hypertension and diabetes.
Study objective
Primary Objective:
To realize a clinically applicable quantification of BBB permeability using
DCE-MRI by determining the reproducibility of the DCE-MRI method
Secondary Objective:
To achieve the shortest scan duration without compromising the reliability of
the BBB permeability quantification.
Study design
A prospective reproducibility and validation study
Study burden and risks
We do not expect the participants to be at any risk during the study and we do
not expect them to benefit from this study directly.
Participants are asked to visit the hospital two times for a dynamic MRI scan.
During these examinations a two-step intravascular injection of contrast agent
is required. This may lead to an alergic reaction in rare cases. It is possible
that participants will experience the MRI scans as uncomfortable due to the
long scan duration, the small space inside the scanner, and the noise (hearing
protection is obligatory).
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
All subjects:
- Age >18 years old
- The condition of the patient must be well enough to allow participation in the study, which is decided in consultation with the treating physician.;cSVD patients:
- patients who present with a transient ischemic attack (TIA) and cSVD related abnormalities on brain MRI. TIA patients are defined as patients with stroke like symptoms that last no longer than 24 hours. MRI abnormalities include extended white matter lesions, (asymptomatic) lacunar infarcts, microbleeds and enlarged Virchow-Robin spaces. The patients are eligible when the first DCE-MRI scan can be performed 8-12 weeks after the TIA to avoid the acute phase, and the second MRI-scan within four weeks after the first.;Cortical stroke or primary intracerebral hemorrhage patients:
- patients who have a clear clinical presentation of either cortical stroke or primary intracerebral hemorrhage confirmed on brain CT. The patients are eligible when the DCE-MRI scans can be performed within 0-6 weeks of the vascular event and on two subsequent days as the vascular permeability may change significantly on the timescale of weeks.
Exclusion criteria
All subjects:
- History of cerebrovascular disease (e.g. ischemic/hemorrhagic stroke)
- History of other diseases of the central nervous system (e.g. epilepsy, brain tumor, multiple sclerosis)
- Contra-indications for MRI examination: e.g. pacemaker; neurostimulator; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; pregnancy and claustrophobia; brain vessel clamps; denture, which contains magnets.
- Contra-indication for MRI contrast agent: e.g. strong suspicion for impaired kidney function, previous allergic reaction to contrast agent, dialysis patients
- Psychiatric co-morbidity and inability to perform the (DCE-)MRI scans.;cSVD patients
- Patients with a potential cardioembolic source (e.g. atrial fibrillation)
- Stenosis of *50% of one or both internal carotid arteries ;Cortical stroke or primary intracerebral hemorrhage patients:
- Extensive cSVD related abnormalities on brain MRI
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 | NL44496.068.13 |