Small Vessel Diseases: Ultra-realistic Microstructure Computational Model to Refine Individual Treatment (SUMMIT-WP3)

May 21, 2024 updated by: University Hospital, Tours
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Tours, France
        • Recruiting
        • UHT of Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy subjects
MRI and neuropsychological evaluation
Device: MRI
In vivo MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores at neuropsychological evaluation
Time Frame: baseline
Scores at neuropsychological evaluation
baseline
FLAIR and SUMMIT maps (MRI evaluation)
Time Frame: baseline
In vivo FLAIR and SUMMIT maps.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

November 24, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DR220256-SUMMIT
  • DR220256 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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