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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06335004
Other study ID # 926
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date February 28, 2025

Study information

Verified date March 2024
Source IRCCS Eugenio Medea
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date February 28, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 9 Months to 70 Years
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
Italy Scientific Institute IRCCS Eugenio Medea Bosisio Parini Lecco

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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/s0 — View Citation

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. — View Citation

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. — View Citation

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.201 — View Citation

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. — View Citation

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, M — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Extent of white matter lesions T1 values of lesions once at recruitment
Primary Number of perivascular spaces count of perivascular spaces and total volume in disease population once at recruitment
Primary Volume of parasagittal dural space volume of parasagittal dural space in disease population once at recruitment
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