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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06159140
Acronym
SUMMIT-WP3
Enrollment
20
Registered
2023-12-06
Start date
2024-03-26
Completion date
2026-03-31
Last updated
2024-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Vessel Disease

Keywords

MRI

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.

Interventions

DEVICEMRI

In vivo MRI

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
82 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
In vivo and ex vivo MRI measures databaselineWe 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

MeasureTime frameDescription
FLAIR and SUMMIT maps (MRI evaluation)baselineIn vivo FLAIR and SUMMIT maps.
Scores at neuropsychological evaluationbaselineScores at neuropsychological evaluation

Countries

France

Contacts

Primary ContactJean Philippe COTTIER, PHD
jean-philippe.cottier@univ-tours.fr+332 18 37 06 73
Backup ContactChristophe DESTRIEUX, PHD
christophe.destrieux@univ-tours.fr+33247366136

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026