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Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy

Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00861172
Acronym
IRM 3T-SEP
Enrollment
6
Registered
2009-03-13
Start date
2009-02-28
Completion date
2012-07-31
Last updated
2013-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lesions, Multiple Sclerosis

Keywords

Multiple sclerosis, Active plaque, Multimodal analysis, 3T MRI, Weekly follow-up, Physiopathology, Physiopathology of active lesions formation in Multiple Sclerosis using multimodal MR sequences

Brief summary

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.

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.

Interventions

PROCEDURE3T MR scanner

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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Modification of MR parameters before and after the blood brain barrier disruption observed in newly enhancing lesion in MS.each week for 2 months, at 6 month and at 12 month

Secondary

MeasureTime 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.each week for 2 months, at 6 month and at 12 month
Relation between plaques development and cerebral venous structures.each week for 2 months, at 6 month and at 12 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026