Small Vessel DiseaseSUMMIT-WP3NCT06159140
Small Vessel Diseases: Ultra-realistic Microstructure Computational Model to Refine Individual Treatment
A study testing MRI in people with Small Vessel Disease, run by University Hospital, Tours at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 82 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Small Vessel Disease
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 82 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Contraindications to body donation, especially infectious disease (VIH, HBV…) Contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Small Vessel Disease
- Being tested
- MRI
- Keywords
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
In vivo MRI
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | MRI and neuropsychological evaluation Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
Secondary outcomes (2)
FLAIR and SUMMIT maps (MRI evaluation)
In vivo FLAIR and SUMMIT maps.
Measured: baseline
Scores at neuropsychological evaluation
Scores at neuropsychological evaluation
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start26 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Vessel DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159140
- Sponsor's protocol ID
- DR220256-SUMMIT
- Other IDs
- DR220256
- Acronym
- SUMMIT-WP3
- Status last verified
- May 2024
- First submitted
- 24 Nov 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Vessel Diseases: Ultra-realistic Microstructure Computational Model to Refine Individual Treatment
- ClinicalTrials.gov ID
- NCT06159140
- Acronym / sponsor ID
- SUMMIT-WP3 / DR220256-SUMMIT
- Conditions
- Small Vessel Disease
- Keywords
- MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Device: MRIMRI and neuropsychological evaluation |
Who may qualify
- Ages
- 82 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindications to body donation, especially infectious disease (VIH, HBV…) Contraindications to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIIn vivo MRI | Device | Healthy subjects |
Primary outcome
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).
2 secondary outcomes
FLAIR and SUMMIT maps (MRI evaluation)
Time frame: baseline
Scores at neuropsychological evaluation
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Small Vessel Disease, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Philippe COTTIER, PHD (+332 18 37 06 73, jean-philippe.cottier@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vivo and ex vivo MRI measures data (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.