An observational study in Glymphatic System, White Matter Disease and Pediatric Disorder, sponsored by IRCCS Eugenio Medea. Active, not recruiting at 1 site in Italy. Open to participants aged 9 Months to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by IRCCS Eugenio Medea · Observational
The dilation of perivascular spaces can be the result of various etiopathogenetic processes. White matter atrophy can cause enlargement of these perivascular spaces (PVS) but also obstruction of fluid drainage systems (interstitial fluid, ISF) and metabolites, as evidenced by some recent studies. Focal stagnation of liquids and deposition of toxic material induce tissue hypoxia and neuroglial dysfunction. Dilation of PVS can be associated with changes in white matter and microhemorrhages. We want to study these etiopathogenetic phenomena by implementing specific MRI methods.
Primary objective: the quantification of indirect magnetic resonance markers of altered waste drainage systems using validated scales in patients with white matter disease. Secondary objective: the evaluation of white matter alterations in relation to the known anatomical glymphatic pathways by analyzing both structural and diffusion data.
39 studies on the registry are indexed under Leukoencephalopathies; 16 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 28 observational studies indexed under Leukoencephalopathies.
Browse Leukoencephalopathies studies →IRCCS Eugenio Medea is the lead sponsor of 108 studies on the registry; 51 are open to participants now.
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Patients with white matter disease on T2 and FLAIR sequences are included in this study. New MR sequences that can further identify subtle signal intensity changes within these white matter lesions will allow to further characterise them. Some patients will require intravenous gadolinium as part of their diagnostic MR work-up. Research MR sequences will also be acquired after gadolinium admininstration to further improve characterisation of the composition of white matter lesions.
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Exclusion Criteria:
Patients with white matter disease due to genetic or acquired causes. MRI with or without intravenous gadolinium will be performed
Diagnostic Test: Magnetic resonance imaging
Patients undergoing MRI with or without gadolinium for clinical diagnostic purposes, with no known white matter disease.
Diagnostic Test: Magnetic resonance imaging
Patients will undergo a magnetic resonance imaging for clinical purposes to which additional sequences. Post gadolinium research sequences will be acquired only if intravenous gadolinium needs to be administered for clinical purposes.
Extent of white matter lesions
T1 values of lesions
Time frame: once at recruitment
Number of perivascular spaces
count of perivascular spaces and total volume in disease population
Time frame: once at recruitment
Volume of parasagittal dural space
volume of parasagittal dural space in disease population
Time frame: once at recruitment
Plan to share: Undecided
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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