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

NCT06335004 | Active Not Recruiting

• 1 other identifier: 926
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glymphatic System; White Matter Disease; Pediatric Disorder; Perivascular Disease

Keywords

Glymphatic system; white matter disease; perivascular space; diffusion tensor imaging; gadolinium; rare disease

Outcome Measures

Primary Outcomes (3)

• Extent of white matter lesions

  T1 values of lesions

  once at recruitment

• Number of perivascular spaces

  count of perivascular spaces and total volume in disease population

  once at recruitment

• Volume of parasagittal dural space

  volume of parasagittal dural space in disease population

  once at recruitment

Study Arms (2)

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

Diagnostic Test: Magnetic resonance imaging

Patients with no white matter disease

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

Diagnostic Test: Magnetic resonance imaging

Interventions

Magnetic resonance imaging 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 with white matter disease/healthy subjects

Eligibility Criteria

• Age: 9 Months - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• unwilling to participate in research

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

Scientific Institute IRCCS Eugenio Medea

Bosisio Parini, Lecco, 23842, Italy

Location

Related Publications (6)

• 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.

  PMID: 23867200 RESULT

• 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.

  PMID: 32550142 RESULT

• 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.

  PMID: 33014733 RESULT

• 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.

  PMID: 28123166 RESULT

• 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.

  PMID: 30353860 RESULT

• 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.

  PMID: 21259015 RESULT

MeSH Terms

Conditions

Leukoencephalopathies; Rare Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: March 28, 2024
• Study Start: March 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

IT (1)