LeukoaraiosisLEUKOPRINTNCT06181981
Leucoaraiosis and Multimodal MRI With Fingerprinting Technique
An observational study of Leukoaraiosis and Magnetic Resonance Imaging, run by Lille Catholic University at 1 site in France.
Trial summary
Leukoaraiosis (LA) corresponds to an alteration of the encephalic white matter, linked to chronic hypoxia. Its pathophysiology, which has been partially elucidated, is underpinned by chronic changes in the walls of small-caliber perforating arteries, leading to chronic hypoperfusion of the white matter, associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukoaraiosis, Magnetic Resonance Imaging
- What is being tested?
- MRI fingerprinting
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2022to 30 Nov 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient over 40 years of age suffering from leucoaraiosis diagnosed via cerebral MRI or CT scan performed by the St Philibert Hospital (GHICL) imaging department
Who may be able to join
- Patient over 40 years of age
- Suffering from leucoaraiosis
- Diagnosed via cerebral MRI or CT scan performed by the St Philibert Hospital imaging department
- For the groups:
- incidental LA (patients included in group 1): on the MRI, FLAIR images showed the presence of hyperintense white matter lesions, assessed at a minimum FAZEKAS grade 2+2, the origin of which was related to small artery disease discovered incidentally or during acute management in GHICL's neurovascular intensive care unit. The CT scan revealed hypodense patches of deep periventricular white matter, also of minimal Fazekas grade 2+2.
- LA and ischemia (patients included in group 2): on the MRI, FLAIR images show the presence of hyperintense white matter lesions with an extent assessed at a minimum grade of FAZEKAS 2+2: their origin is related to small artery disease discovered during acute management of cerebral ischemia in the GHICL's Neurovascular Intensive Care Unit.
- LA and cerebral hemorrhage (patients included in group 3): on the MRI, FLAIR images show the presence of hyperintense white matter lesions of minimal FAZEKAS grade 2+2: their origin is related to small artery disease discovered during the acute management of a cerebral hemorrhage, in the GHICL's Neurovascular Intensive Care Unit.
Who cannot join
- Claustrophobia preventing MRI scan
- MRI contraindication
- White matter lesions with diagnosis not formally established, doubtful, multifactorial or related to a differential diagnosis
- Patients with dementia or pathology that precludes longitudinal follow-up
- Institutionalized patients
- Agitation not allowing MRI to be performed
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- Pregnant women
- Patients under guardianship
- Patients objecting the use of their data
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Grupement des Hôpitaux de l'Institut Catholique de Lille
Lomme, 59462
Lebitasy Marie-Paule, MD, 00 33 3 20 22 57 41, Lebitasy_Marie-Paule <Lebitasy.Marie-Paule@ghicl.net>
About this study
Official title: Longitudinal Evaluation of Leucoaraiosis Using Multimodal MRI With Fingerprinting Technique
Leukoaraiosis (LA) corresponds to an alteration of the encephalic white matter, linked to chronic hypoxia. Its pathophysiology, which has been partially elucidated, is underpinned by chronic changes in the walls of small-caliber perforating arteries, leading to chronic hypoperfusion of the white matter, associated with dysfunction of the blood-brain barrier. In affected areas, this process leads to myelin rarefaction, axonal loss, perivascular alterations and the appearance of cavitation zones. Its existence is mainly linked to the presence of vascular risk factors, most notably arterial hypertension.
MR fingerprinting is an innovative Magnetic resonance Imaging (MRI) technique allowing to obtain a multiparametric MRI sequence in a non-invasively way and in a single acquisition, generating not only multiple contrasts, but also absolute longitudinal relaxation time (T1) and transverse relaxation time (T2) mappings (T1 and T2 mapping). However, the prognostic role of these T2 values, in terms of ischemic, hemorrhagic and cognitive risk, has never been studied. The objective of this study is to study and compare changes in T1 and T2 values of White Matter Hyperintensities (WMH) and Normal Appearing White Matter (NAWM) in subjects with LA.
- Conditions
- Leukoaraiosis, Magnetic Resonance Imaging
- Being tested
- MRI fingerprinting
- Keywords
- Leukoaraiosis, Magnetic Resonance Imaging, White Matter Hyperintensities (WMH), Normal Appearing White Matter (NAWM)
- Medical subject headings
- Leukoaraiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI fingerprintingDiagnostic test
This method allows to get quantitative magnetic resonance imaging for the simultaneous measurement of multiple tissue properties in a single, time-efficient acquisition
| Study group | Role | What they receive |
|---|---|---|
| incidental Leukoaraiosis (LA) | Eligible patients in the incidental LA group will be pre-identified by the radiologist at the time of the 3T MRI or CT scan, and recruited by the neurologist at their first routine neurology consultation in the days following the MRI. Receives: Diagnostic Test: MRI fingerprinting | |
| LA and ischemic stroke | Eligible patients in the LA + ischemic stroke group will be recruited by the neurologist during hospitalization for ischemic stroke Receives: Diagnostic Test: MRI fingerprinting | |
| LA and intracerebral hemorrhage | Eligible patients in the LA + intracerebral hemorrhage group will be recruited by the neurologist during hospitalization Receives: Diagnostic Test: MRI fingerprinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
T1 (seconds)
T1 will be measured by three-dimensional, magnetization-prepared rapid gradient-echo (3D MP-RAGE) imaging
Measured: 30 months
T2 (milliseconds)
T2 will be measured by three-dimensional segmented echo-planar-imaging (3D T2 EPI)
Measured: 30 months
Secondary outcomes (2)
Correlation coefficient and its 95% confidence interval between WMH T1 and T2 values, and WHM lesion volume.
Correlation between T1 and T2 values and WHM lesion volume will be assessed by Pearson's or Spearman's correlation coefficient in the absence of normality, and its 95% confidence interval. Correlation will be considered very good if |ρ| > 0.8; good if |ρ| is between 0.61 and 0.8; moderate if |ρ| is between 0.6 and 0.41; poor otherwise.
Measured: 30 months
Correlation coefficient and its 95% confidence interval between T1 and T2 values of WMH and NAWM, lesion volume of WMH, and number of microbleeds
Correlation between T1 and T2 values and WHM lesion volume will be assessed by Pearson's or Spearman's correlation coefficient in the absence of normality, and its 95% confidence interval. Correlation will be considered very good if |ρ| > 0.8; good if |ρ| is between 0.61 and 0.8; moderate if |ρ| is between 0.6 and 0.41; poor otherwise.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start14 Nov 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukoaraiosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Sébastien VERCLYTTE, MD, Study director, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181981
- Sponsor's protocol ID
- RNIPH-2022-03
- Acronym
- LEUKOPRINT
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Leucoaraiosis Using Multimodal MRI With Fingerprinting Technique
- ClinicalTrials.gov ID
- NCT06181981
- Acronym / sponsor ID
- LEUKOPRINT / RNIPH-2022-03
- Conditions
- Leukoaraiosis, Magnetic Resonance Imaging
- Keywords
- Leukoaraiosis, Magnetic Resonance Imaging, White Matter Hyperintensities (WMH), Normal Appearing White Matter (NAWM)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 26 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.
Leukoaraiosis (LA) corresponds to an alteration of the encephalic white matter, linked to chronic hypoxia. Its pathophysiology, which has been partially elucidated, is underpinned by chronic changes in the walls of small-caliber perforating arteries, leading to chronic hypoperfusion of the white matter, associated with dysfunction of the blood-brain barrier. In affected areas, this process leads to myelin rarefaction, axonal loss, perivascular alterations and the appearance of cavitation zones. Its existence is mainly linked to the presence of vascular risk factors, most notably arterial hypertension.
MR fingerprinting is an innovative Magnetic resonance Imaging (MRI) technique allowing to obtain a multiparametric MRI sequence in a non-invasively way and in a single acquisition, generating not only multiple contrasts, but also absolute longitudinal relaxation time (T1) and transverse relaxation time (T2) mappings (T1 and T2 mapping). However, the prognostic role of these T2 values, in terms of ischemic, hemorrhagic and cognitive risk, has never been studied. The objective of this study is to study and compare changes in T1 and T2 values of White Matter Hyperintensities (WMH) and Normal Appearing White Matter (NAWM) in subjects with LA.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| incidental Leukoaraiosis (LA) | – | Diagnostic Test: MRI fingerprintingEligible patients in the incidental LA group will be pre-identified by the radiologist at the time of the 3T MRI or CT scan, and recruited by the neurologist at their first routine neurology consultation in the days following the MRI. |
| LA and ischemic stroke | – | Diagnostic Test: MRI fingerprintingEligible patients in the LA + ischemic stroke group will be recruited by the neurologist during hospitalization for ischemic stroke |
| LA and intracerebral hemorrhage | – | Diagnostic Test: MRI fingerprintingEligible patients in the LA + intracerebral hemorrhage group will be recruited by the neurologist during hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient over 40 years of age suffering from leucoaraiosis diagnosed via cerebral MRI or CT scan performed by the St Philibert Hospital (GHICL) imaging department
Key inclusion criteria (7 listed)
- Patient over 40 years of age
- Suffering from leucoaraiosis
- Diagnosed via cerebral MRI or CT scan performed by the St Philibert Hospital imaging department
- incidental LA (patients included in group 1): on the MRI, FLAIR images showed the presence of hyperintense white matter lesions, assessed at a minimum FAZEKAS grade 2+2, the origin of which was related to small artery disease discovered incidentally or during acute management in GHICL's neurovascular intensive care unit. The CT scan revealed hypodense patches of deep periventricular white matter, also of minimal Fazekas grade 2+2.
- LA and ischemia (patients included in group 2): on the MRI, FLAIR images show the presence of hyperintense white matter lesions with an extent assessed at a minimum grade of FAZEKAS 2+2: their origin is related to small artery disease discovered during acute management of cerebral ischemia in the GHICL's Neurovascular Intensive Care Unit.
Key exclusion criteria (9 listed)
- Claustrophobia preventing MRI scan
- MRI contraindication
- White matter lesions with diagnosis not formally established, doubtful, multifactorial or related to a differential diagnosis
- Patients with dementia or pathology that precludes longitudinal follow-up
- Institutionalized patients
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 |
|---|---|---|
| MRI fingerprintingThis method allows to get quantitative magnetic resonance imaging for the simultaneous measurement of multiple tissue properties in a single, time-efficient acquisition | Diagnostic test | LA and intracerebral hemorrhage, LA and ischemic stroke, incidental Leukoaraiosis (LA) |
Primary outcome
T1 (seconds)
Time frame: 30 months
T1 will be measured by three-dimensional, magnetization-prepared rapid gradient-echo (3D MP-RAGE) imaging
T2 (milliseconds)
Time frame: 30 months
T2 will be measured by three-dimensional segmented echo-planar-imaging (3D T2 EPI)
2 secondary outcomes
Correlation coefficient and its 95% confidence interval between WMH T1 and T2 values, and WHM lesion volume.
Time frame: 30 months
Correlation coefficient and its 95% confidence interval between T1 and T2 values of WMH and NAWM, lesion volume of WMH, and number of microbleeds
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Sébastien VERCLYTTE, MD study director
Groupement des Hôpitaux de l'Institut Catholique de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukoaraiosis and Magnetic Resonance Imaging, run by Lille Catholic University 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 7 inclusion and 9 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 26 Dec 2023. 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 Marie Paule LEBITASY, MD (00 33 3 20 22 57 41, Lebitasy.Marie-Paule@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T1 (seconds) (time frame: 30 months). The study lists 2 primary outcomes in all. 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 26 Dec 2023.