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

Small Vessel Disease Clinical Trial

— SUMMIT-WP3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159140
• Other study ID #: DR220256-SUMMIT
• Secondary ID: DR220256
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Tours
• Contact: Jean Philippe COTTIER, PHD
• Phone: +332 18 37 06 73
• Email: jean-philippe.cottier[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 82 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Small Vessel Disease

Intervention

Device:
• MRI
In vivo MRI

Locations

Country	Name	City	State
France	UHT of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In vivo and ex vivo MRI measures data	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).	baseline
Secondary	FLAIR and SUMMIT maps (MRI evaluation)	In vivo FLAIR and SUMMIT maps.	baseline
Secondary	Scores at neuropsychological evaluation	Scores at neuropsychological evaluation	baseline