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MRI measurements of the brain vessel walls in patients with cerebral vasculitis


- candidate number23945
- NTR NumberNTR5748
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-feb-2016
- Secondary IDsNL43684.041.13 Institutional Review Board University Medical Center Utrecht
- Public TitleMRI measurements of the brain vessel walls in patients with cerebral vasculitis
- Scientific TitleDiagnosing cerebral vasculitis using MR intracranial vessel wall imaging at 7.0 tesla’
- ACRONYMDIVA study
- hypothesisAn accurate diagnosis of cerebral vasculitis remains challenging due to limited sensitivity and specificity of different diagnostic modalities. A diagnostic test with excellent properties for visualising the intracranial vessel wall could help making a correct and early diagnosis of cerebral vasculitis. Therefore, in the current study, we will develop a non-invasive method for the detection of cerebral vasculitis. We hypothese that we can detect cerebral vasculitis in an early stage of the disease
- Healt Condition(s) or Problem(s) studiedVasculitis, MRI
- Inclusion criteriaInclusion criteria for healthy volunteers
- 18 years or older

Inclusion criteria for patients
- 18 years or older
- Ready for MRI before starting treatment of cerebral vasculitis(if applicable)
- Suspected cerebral vasculitis
- Exclusion criteriaExclusion criteria for healthy volunteers
- Allergic reaction to gadolinium
- Impaired renal function (severe renal insufficiency, GFR <30ml/min/1,73m2; or nephrogenic systemic fibrosis/ nephrogenic fibrosing nephropathy (NSF/NFG))
- Impossibility to undergo MRI (claustrophobia, implants or metal objects in or around the body)
- Pregnancy
- Previous history of cerebral vasculitis or other cerebrovascular diseases
- Malign brain tumour or brain tumours treated with radiotherapy

Exclusion criteria for patients
- Allergic reaction to gadolinium
- Patients who are already treated with medication for cerebral vasculitis when included
- Patients with impaired renal function (severe renal insufficiency, GFR <30ml/min/1,73m2; or nephrogenic systemic fibrosis/ nephrogenic fibrosing nephropathy (NSF/NFG))
- Impossibility to undergo MRI (claustrophobia, implants or metal objects in or around the body)
- Pregnancy
- Malign brain tumour or brain tumours treated with radiotherapy
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-aug-2013
- planned closingdate1-aug-2016
- Target number of participants80
- InterventionsN/A
- Primary outcomeThe main research question is to compare the diagnostic accuracy of 7T MRI for cerebral vasculitis, with the standard diagnostic practice (SDP). The true nature of the disease will be assessed for all patients at the end of the study by re-evaluation of the patients, assessing either response to treatment or recurrent symptoms (Reference standard, RS). The goal of the study is to compare both the sensitivities and specificities of the two diagnostic tests.
- Secondary outcomeOur second objective is to compare the intracranial vessel wall abnormalities found in patients to the abnormalities found in healthy volunteers.

Our third objective is to investigate whether changes of the intracranial vessel wall occur between baseline and follow-up.
- TimepointsPatients will undergo 2 7T MRI scans: one during hospital administration and one after 6 months.

Healthy volunteers will undergo 1 7T MRI scan at baseline.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Nikki Dieleman
- CONTACT for SCIENTIFIC QUERIES Nikki Dieleman
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsDieleman, Patterns of intracranial vessel wall changes in relation to ischemic infarcts, Neurology, 2014
- Brief summaryThe cerebral vasculitides are a heterogeneous group of diseases. Early diagnostic discrimination between the cerebral vasculitides and other vessel wall diseases (vasculopathies) is, however, essential since they can have devastating consequences, often in relatively young patients, if not promptly and adequately treated.

After exclusion of non-inflammatory or cardiac embolic causes of stroke by extracranial and intracranial vessel assessment and cardiac investigations, an accurate diagnosis remains challenging due to limited sensitivity and specificity of different diagnostic modalities like Magnetic Resonance Imaging (MRI), Cerebrospinal Fluid (CSF) examination, angiography, and brain biopsy1, 2 for the diagnosis of cerebral vasculitis.

A diagnostic test with excellent properties for visualising the intracranial vessel wall could help making a correct and early diagnosis of cerebral vasculitis. Therefore, in the current study, we will develop a non-invasive method for the detection of cerebral vasculitis. Based upon the intracranial vessel wall sequence, developed by the 7T group and used in an on-going study (IVI study), a 7.0 tesla MR protocol will be developed and optimized for the visualization of the intracranial arterial wall in patients suspected of cerebral vasculitis. With our protocol we will be able to visualize both normal intracranial vessel wall as well as vessel wall abnormalities. Together with the IVI-study and the PIVI-study, in which the intracranial causes of ischemic stroke of the anterior and posterior circulation, respectively, will be assessed, this study will provide better insight in the underlying pathological vessel wall changes in a large group of neurological patients.
- Main changes (audit trail)
- RECORD10-feb-2016 - 22-mei-2016


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