Evaluation of Brain Waste Clearance Pathways Using Magnetic Resonance Imaging in Pediatric Patients With White Matter Diseases

NCT ID: NCT06335004

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Glymphatic System White Matter Disease Pediatric Disorder Perivascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with white matter disease/healthy subjects

Patients with white matter disease due to genetic or acquired causes. MRI with or without intravenous gadolinium will be performed

Magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

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.

Patients with no white matter disease

Patients undergoing MRI with or without gadolinium for clinical diagnostic purposes, with no known white matter disease.

Magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients with and without white matter disease
* patients willing to participate in research with signed consent form
* no age limit (results will be age matched)

Exclusion Criteria

* unwilling to participate in research
Minimum Eligible Age

9 Months

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Eugenio Medea

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Scientific Institute IRCCS Eugenio Medea

Bosisio Parini, Lecco, Italy

Site Status

Countries

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Italy

References

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Wardlaw JM, Smith EE, Biessels GJ, Cordonnier C, Fazekas F, Frayne R, Lindley RI, O'Brien JT, Barkhof F, Benavente OR, Black SE, Brayne C, Breteler M, Chabriat H, Decarli C, de Leeuw FE, Doubal F, Duering M, Fox NC, Greenberg S, Hachinski V, Kilimann I, Mok V, Oostenbrugge Rv, Pantoni L, Speck O, Stephan BC, Teipel S, Viswanathan A, Werring D, Chen C, Smith C, van Buchem M, Norrving B, Gorelick PB, Dichgans M; STandards for ReportIng Vascular changes on nEuroimaging (STRIVE v1). Neuroimaging standards for research into small vessel disease and its contribution to ageing and neurodegeneration. Lancet Neurol. 2013 Aug;12(8):822-38. doi: 10.1016/S1474-4422(13)70124-8.

Reference Type RESULT
PMID: 23867200 (View on PubMed)

Ma YJ, Fan S, Shao H, Du J, Szeverenyi NM, Young IR, Bydder GM. Use of Multiplied, Added, Subtracted and/or FiTted Inversion Recovery (MASTIR) pulse sequences. Quant Imaging Med Surg. 2020 Jun;10(6):1334-1369. doi: 10.21037/qims-20-568.

Reference Type RESULT
PMID: 32550142 (View on PubMed)

Ma YJ, Shao H, Fan S, Lu X, Du J, Young IR, Bydder GM. New options for increasing the sensitivity, specificity and scope of synergistic contrast magnetic resonance imaging (scMRI) using Multiplied, Added, Subtracted and/or FiTted (MASTIR) pulse sequences. Quant Imaging Med Surg. 2020 Oct;10(10):2030-2065. doi: 10.21037/qims-20-795.

Reference Type RESULT
PMID: 33014733 (View on PubMed)

Naganawa S, Nakane T, Kawai H, Taoka T. Lack of Contrast Enhancement in a Giant Perivascular Space of the Basal Ganglion on Delayed FLAIR Images: Implications for the Glymphatic System. Magn Reson Med Sci. 2017 Apr 10;16(2):89-90. doi: 10.2463/mrms.ci.2016-0114. Epub 2017 Jan 25. No abstract available.

Reference Type RESULT
PMID: 28123166 (View on PubMed)

Rasmussen MK, Mestre H, Nedergaard M. The glymphatic pathway in neurological disorders. Lancet Neurol. 2018 Nov;17(11):1016-1024. doi: 10.1016/S1474-4422(18)30318-1.

Reference Type RESULT
PMID: 30353860 (View on PubMed)

Hawkes CA, Hartig W, Kacza J, Schliebs R, Weller RO, Nicoll JA, Carare RO. Perivascular drainage of solutes is impaired in the ageing mouse brain and in the presence of cerebral amyloid angiopathy. Acta Neuropathol. 2011 Apr;121(4):431-43. doi: 10.1007/s00401-011-0801-7. Epub 2011 Jan 23.

Reference Type RESULT
PMID: 21259015 (View on PubMed)

Other Identifiers

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926

Identifier Type: -

Identifier Source: org_study_id

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