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RecruitingNCT06159140SUMMIT-WP3Updated May 23, 2024

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

An interventional study of MRI in Small Vessel Disease, sponsored by University Hospital, Tours. Recruiting at 1 site in France. Open to participants aged 82 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-23.

Sponsored by University Hospital, Tours · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
82 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Small Vessel Disease

Keywords

  • MRI
03

In context

Lead sponsor

University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
82 Years to 100 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Healthy subjects

    MRI and neuropsychological evaluation

    Device: MRI

Interventions

  • DeviceMRI

    In vivo MRI

06

What researchers measure

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).

    Time frame: baseline

Secondary outcomes

  1. FLAIR and SUMMIT maps (MRI evaluation)

    In vivo FLAIR and SUMMIT maps.

    Time frame: baseline

  2. Scores at neuropsychological evaluation

    Scores at neuropsychological evaluation

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
  • UHT of Tours
    Tours, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06159140
Lead sponsor
University Hospital, Tours
Responsible party
Sponsor
First posted
Dec 6, 2023
Start date
Mar 26, 2024
Primary completion
Mar 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
May 23, 2024

Study contacts

Jean Philippe COTTIER, PHD
Contact
jean-philippe.cottier@univ-tours.fr
+332 18 37 06 73
Christophe DESTRIEUX, PHD
Contact
christophe.destrieux@univ-tours.fr
+33247366136

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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