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Clinical Trials/NCT06159140
NCT06159140
Recruiting
N/A

Small Vessel Diseases: Ultra-realistic Microstructure Computational Model to Refine Individual Treatment

University Hospital, Tours1 site in 1 country20 target enrollmentMarch 26, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Small Vessel Disease
Sponsor
University Hospital, Tours
Enrollment
20
Locations
1
Primary Endpoint
In vivo and ex vivo MRI measures data
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Small vessel disease (SVD) accounts for 25% of strokes and is the second most common cause of dementia after Alzheimer's disease. Unlike other causes of stroke, SVD manifests itself years before the stroke by the accumulation of tissue damage. Although heterogeneous, these lesions appear on Magnetic Resonance Imaging (MRI) as white matter hypersignals (WMH). In this context, the ANR SUMMIT project will characterize these lesions in vivo to develop new markers in the early stages of stroke. It is subdivided into 4 work packages, the third one being promoted by CHRU de Tours.

Registry
clinicaltrials.gov
Start Date
March 26, 2024
End Date
March 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Prior Enrollement in Tours body donation program Age ≥ 82 years Able to remain supine in the MR scanner for acquisition (duration 60-minutes) Affiliation to social security Informed and written consent

Exclusion Criteria

  • Contraindications to body donation, especially infectious disease (VIH, HBV...) Contraindications to MRI

Outcomes

Primary Outcomes

In vivo and ex vivo MRI measures data

Time Frame: baseline

We will compare In vivo data: 20 MR datasets, 20 quantitative SUMMIT maps (predicted microstructure) Ex vivo data : * 3 very high-resolution MR datasets and derived quantitative microstructural maps * 18 brain samples: scanned at 17.2T by the Neurospin partner and processed with the SUMMIT method to obtain high-resolution quantitative microstructural maps * these 18 samples will be processed to get ground truth histological 3D volumes (Mircen partner). Maps of the microstructure parameters obtained from MRI (in and ex vivo) and the SUMMIT method will be quantitatively compared to histological data. This will validate the SUMMIT method at clinical (in vivo) and mesoscopic resolution (ex vivo).

Secondary Outcomes

  • Scores at neuropsychological evaluation(baseline)
  • FLAIR and SUMMIT maps (MRI evaluation)(baseline)

Study Sites (1)

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