- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00861172
Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy (IRM 3T-SEP)
It is difficult to determinate prognostic criteria of Multiple Sclerosis with conventional MRI insofar as physiopathology is not well-known: the precise sequences of events leading to plaque formation and axonal injury are still not completely understood.
Some elements involved in plaque formation can be studied thanks to MR techniques (cerebrospinal fluid and periveinular spaces, neuronal injury, microglia, and cerebral microcirculation's dysfunction).
This study aims at giving a better understanding of MS plaques' physiopathology, using data from modern MRI through a longitudinal followed up with weakly MR 3T examination.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of this work are:
- study weakly development of the active MS plaque with multimodal MRI parameters using advanced MRI techniques: Veinography/3D FLAIR, Diffusion (CDA), Perfusion (CBV, CBF, MTT) MR Spectroscopy (NAA, myo-inositol, choline, lactate…) and enhanced 3DT1 sequences.
- define prognostic markers of MS aggressiveness ("black holes")
- Study development of MS plaque around venous structures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
BRON Cedex, France, 69677
- Services de Neurologie A et Service de Neuroradiologie, Pôle transversal d'imagerie, Hôpital Neurologique
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 18 and 50 years.
- Health coverage.
- Any form of MS defined by Mc Donald's criteria (2005).
- Patients having shown an enhanced plaque on a less than six month MRI examination.
Exclusion Criteria:
- Patients with an immunomodulating therapy like natalizumab (Tysabri) and intravenous immunosuppressive therapies. Other therapies will not be excluded from this study. For patients treated by systemic corticotherapy, a one-month delay will be necessary before a MRI examination.
- Cerebral microangiopathy (diabetes, arterial hypertension, vascularitis…)
- Patient with classical MRI contraindication like pace-maker, cardiac valvulosis, claustrophobia, allergy to contrast agent …
- Pregnancy or pregnancy desire.
- Patient with a low creatinine clearance <60 ml/mn
Study Plan
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
|
The follow-up will be scheduled for one year; it will consist in a weekly MR examination during the first two months, and subsequently on the 6th and the 12th months. We will perform for each MRI exploration an intravenous injection of contrast agents: gadobutrol (gadovist 1,0 mmol/ml) which is a stable agent with a cyclic structure. This agent is few responsible for NFS, given their low capacity to liberate gadolinium GD3+ in tissues. The same imaging protocol will be performed for each MR examination. Evaluation of creatinemia will be used before inclusion and during the 1st, 3rd, 5th, 7th, 9th, and the 10th MRI examination. Thus we will take advantage of catheter to perform the creatinemia blood test and to reduce the discomfort produced by the injection. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modification of MR parameters before and after the blood brain barrier disruption observed in newly enhancing lesion in MS.
Time Frame: each week for 2 months, at 6 month and at 12 month
|
each week for 2 months, at 6 month and at 12 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Predictive scorers of plaque transformation in "black-holes", which correspond with a pejorative evolution of accurate lesions, also defined by a focal destruction of cerebral tissue.
Time Frame: each week for 2 months, at 6 month and at 12 month
|
each week for 2 months, at 6 month and at 12 month
|
Relation between plaques development and cerebral venous structures.
Time Frame: each week for 2 months, at 6 month and at 12 month
|
each week for 2 months, at 6 month and at 12 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francois Cotton, Pr, Hospices Civils de Lyon
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008.532
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 Multiple Sclerosis
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
Brigham and Women's HospitalMassachusetts General HospitalRecruitingMultiple Sclerosis | Relapsing Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
University of MinnesotaMallinckrodtTerminatedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
Clinical Trials on 3T MR scanner
-
Cedars-Sinai Medical CenterRecruitingCoronary Artery Disease | CancerUnited States
-
University of MiamiRecruitingGlioma | Brain Tumor | Malignant Glioma | Primary Brain Tumor | Malignant Primary Brain TumorUnited States
-
National Cancer Institute (NCI)RecruitingGlioma | High Grade Glioma | Malignant Glioma | Gliomas | Low Grade GliomaUnited States
-
London Health Sciences CentreUniversity of Western Ontario, Canada; London Regional Cancer Program, CanadaTerminated
-
University of MinnesotaCompleted
-
Max Planck Institute for Human Cognitive and Brain...Hannover Medical School; Leipzig University Medical CenterNot yet recruitingTourette Syndrome | Gilles de la Tourette SyndromeGermany
-
Institut National de la Santé Et de la Recherche...Unknown
-
Mayo ClinicCompletedProstate AdenocarcinomaUnited States
-
Christine Elizabeth EdmondsWithdrawn
-
Cambridge University Hospitals NHS Foundation TrustNational Institute for Health Research, United Kingdom; Wolfson Brain Imaging...RecruitingCervical Spondylosis With Myelopathy | Degenerative Cervical MyelopathyUnited Kingdom