Leucoaraiosis and Multimodal MRI With Fingerprinting Technique

Magnetic Resonance Imaging Clinical Trial

— LEUKOPRINT  

Official title:

Longitudinal Evaluation of Leucoaraiosis Using Multimodal MRI With Fingerprinting Technique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181981
• Other study ID #: RNIPH-2022-03
• Status: Recruiting
• Start date: November 14, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: December 2023
• Source: Lille Catholic University
• Contact: Marie Paule LEBITASY, MD
• Phone: 00 33 3 20 22 57 41
• Email: Lebitasy.Marie-Paule[@]ghicl.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Leukoaraiosis (LA) corresponds to an alteration of the encephalic white matter, linked to chronic hypoxia. Its pathophysiology, which has been partially elucidated, is underpinned by chronic changes in the walls of small-caliber perforating arteries, leading to chronic hypoperfusion of the white matter, associated with dysfunction of the blood-brain barrier. In affected areas, this process leads to myelin rarefaction, axonal loss, perivascular alterations and the appearance of cavitation zones. Its existence is mainly linked to the presence of vascular risk factors, most notably arterial hypertension.

MR fingerprinting is an innovative Magnetic resonance Imaging (MRI) technique allowing to obtain a multiparametric MRI sequence in a non-invasively way and in a single acquisition, generating not only multiple contrasts, but also absolute longitudinal relaxation time (T1) and transverse relaxation time (T2) mappings (T1 and T2 mapping). However, the prognostic role of these T2 values, in terms of ischemic, hemorrhagic and cognitive risk, has never been studied. The objective of this study is to study and compare changes in T1 and T2 values of White Matter Hyperintensities (WMH) and Normal Appearing White Matter (NAWM) in subjects with LA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 40 years of age

• Suffering from leucoaraiosis

• Diagnosed via cerebral MRI or CT scan performed by the St Philibert Hospital imaging department

For the groups:

• incidental LA (patients included in group 1): on the MRI, FLAIR images showed the presence of hyperintense white matter lesions, assessed at a minimum FAZEKAS grade 2+2, the origin of which was related to small artery disease discovered incidentally or during acute management in GHICL's neurovascular intensive care unit. The CT scan revealed hypodense patches of deep periventricular white matter, also of minimal Fazekas grade 2+2.

• LA and ischemia (patients included in group 2): on the MRI, FLAIR images show the presence of hyperintense white matter lesions with an extent assessed at a minimum grade of FAZEKAS 2+2: their origin is related to small artery disease discovered during acute management of cerebral ischemia in the GHICL's Neurovascular Intensive Care Unit.

• LA and cerebral hemorrhage (patients included in group 3): on the MRI, FLAIR images show the presence of hyperintense white matter lesions of minimal FAZEKAS grade 2+2: their origin is related to small artery disease discovered during the acute management of a cerebral hemorrhage, in the GHICL's Neurovascular Intensive Care Unit.

Exclusion Criteria:

• Claustrophobia preventing MRI scan

• MRI contraindication

• White matter lesions with diagnosis not formally established, doubtful, multifactorial or related to a differential diagnosis

• Patients with dementia or pathology that precludes longitudinal follow-up

• Institutionalized patients

• Agitation not allowing MRI to be performed

• Pregnant women

• Patients under guardianship

• Patients objecting the use of their data

Related Conditions & MeSH terms

• Leukoaraiosis
• Magnetic Resonance Imaging

Intervention

Diagnostic Test:
• MRI fingerprinting
This method allows to get quantitative magnetic resonance imaging for the simultaneous measurement of multiple tissue properties in a single, time-efficient acquisition

Locations

Country	Name	City	State
France	Grupement des Hôpitaux de l'Institut Catholique de Lille	Lomme

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T1 (seconds)	T1 will be measured by three-dimensional, magnetization-prepared rapid gradient-echo (3D MP-RAGE) imaging	30 months
Primary	T2 (milliseconds)	T2 will be measured by three-dimensional segmented echo-planar-imaging (3D T2 EPI)	30 months
Secondary	Correlation coefficient and its 95% confidence interval between WMH T1 and T2 values, and WHM lesion volume.	Correlation between T1 and T2 values and WHM lesion volume will be assessed by Pearson's or Spearman's correlation coefficient in the absence of normality, and its 95% confidence interval. Correlation will be considered very good if |?| > 0.8; good if |?| is between 0.61 and 0.8; moderate if |?| is between 0.6 and 0.41; poor otherwise.	30 months
Secondary	Correlation coefficient and its 95% confidence interval between T1 and T2 values of WMH and NAWM, lesion volume of WMH, and number of microbleeds	Correlation between T1 and T2 values and WHM lesion volume will be assessed by Pearson's or Spearman's correlation coefficient in the absence of normality, and its 95% confidence interval. Correlation will be considered very good if |?| > 0.8; good if |?| is between 0.61 and 0.8; moderate if |?| is between 0.6 and 0.41; poor otherwise.	30 months