Small Vessel Diseases: Ultra-realistic Microstructure Computational Model to Refine Individual Treatment
SUMMIT-WP3
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2023
CompletedFirst Posted
Study publicly available on registry
December 6, 2023
CompletedStudy Start
First participant enrolled
March 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedMay 23, 2024
May 1, 2024
1.9 years
November 24, 2023
May 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
FLAIR and SUMMIT maps (MRI evaluation)
baseline
Scores at neuropsychological evaluation
baseline
Study Arms (1)
Healthy subjects
EXPERIMENTALMRI and neuropsychological evaluation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contraindications to body donation, especially infectious disease (VIH, HBV…) Contraindications to MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UHT of Tours
Tours, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2023
First Posted
December 6, 2023
Study Start
March 26, 2024
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
May 23, 2024
Record last verified: 2024-05