- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04907487
Évaluation de l'Impact du Compressed Sensing Sur le Signal QSM (CS-QSM)
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which a maximum of four additional 25-minute sequences will be added.
MRI of routine care includes at least the following sequences:
- 3D T1 TFE (2 minutes)
- T2 TSE (2 minutes)
- 3D FLAIR (3 minutes)
The sequences added by the research lasting 25 minutes are:
- SWI QSM 1.0iso 8 echoes (10 minutes)
- SWI QSM 1.0iso 8 echoes CS 6 (7 minutes)
- SWI QSM 1.0iso 8 echoes CS 9 (5 minutes)
- SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)
Study Overview
Detailed Description
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which a maximum of four additional 25-minute sequences will be added.
MRI of routine care includes at least the following sequences:
- 3D T1 TFE (2 minutes)
- T2 TSE (2 minutes)
- 3D FLAIR (3 minutes)
The sequences added by the research lasting 25 minutes are:
- SWI QSM 1.0iso 8 echoes (10 minutes)
- SWI QSM 1.0iso 8 echoes CS 6 (7 minutes)
- SWI QSM 1.0iso 8 echoes CS 9 (5 minutes)
- SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Paris
-
Paris, Paris, France, 75019
- Hhopital fondation adolphe de rothschild
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Two groups of patients will be included as part of this research protocol:
- Group I: Patients with MS
- Group II: Patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS pathology, age and gender matched with group I.
Description
Inclusion Criteria:
For patients with MS:
- Patient over 18 years old
- Presenting MS defined according to McDonald's revised criteria for spatial and temporal clinical or radiological dissemination [16],
- Should benefit as part of the care of an MRI examination with or without injection of gadolinium
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease:
- Patient over 18 years old
- Should benefit as part of the care of an MRI examination with or without injection of gadolinium
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
Exclusion Criteria:
- For patients with MS:
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease:
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- Patient with inflammatory and / or demyelinating pathology of the CNS
Secondary exclusion criteria :
- Motion artefact not allowing interpretation of images
- Patient who did not perform one of the following sequences: 3D T1 TFE, 3D FLAIR (for MS patients), SWI QSM 1.0iso 8 echoes.
Secondarily excluded patients will be replaced.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
SEP
With Multiple Sclerosis as defined by McDonald's revised clinical or radiological spatial and temporal dissemination criteria
|
MRI of routine care includes at least the following sequences:
The sequences added by the research lasting 25 minutes are:
|
|
NO SEP
For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease
|
MRI of routine care includes at least the following sequences:
The sequences added by the research lasting 25 minutes are:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
concordance of QSM signal with and without compressed-sensing in white matter
Time Frame: 1 DAY
|
concordance of QSM signal with and without compressed-sensing in white matter
|
1 DAY
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- JSY_2021_13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on MRI
-
Assaf-Harofeh Medical CenterRecruitingMRI, Functional MRIIsrael
-
Centre Hospitalier Universitaire de NīmesRecruiting
-
PfizerCompletedMRI SedationUnited States, Japan
-
University of UtahWithdrawnMRI ScansUnited States
-
Rennes University HospitalRecruiting
-
Atridia Pty Ltd.Completed
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
University of LiegeUnknown
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting
Clinical Trials on MRI
-
Cambridge University Hospitals NHS Foundation TrustRecruitingBreast CancerUnited Kingdom
-
Seoul National University Bundang HospitalBayerCompletedTraumaKorea, Republic of
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedOsteosarcoma | Ewing Sarcoma | Paget's DiseaseUnited States
-
Assistance Publique Hopitaux De MarseilleActive, not recruitingMultiple SclerosisFrance
-
Abbott Medical DevicesCompletedAdverse Effect of MRI on an Implanted Pacemaker Lead | Adverse Effect of MRI on an Implanted PacemakerUnited States, Netherlands, Australia, Belgium, Finland
-
Centre Hospitalier Universitaire de Saint EtienneLohmann & RauscherRecruitingLow Back Pain | Healthy VolunteerFrance
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingPatients with Atrial Fibrillation and Healthy Volunters
-
University of EdinburghCompleted
-
Assistance Publique - Hôpitaux de ParisUnknownBrain Injury, Coma | Cardiac Arrest (CA) | Traumatic Brain Injury (TBI) | Aneurysmal Subarachnoid Hemorrhages (aSAH)France
-
Sheba Medical CenterUnknown