Clinical Trials Directory

Trials / Completed

CompletedNCT00861172

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
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURE3T MR scannerThe 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.

Timeline

Start date
2009-02-01
Primary completion
2012-07-01
Completion
2012-07-01
First posted
2009-03-13
Last updated
2013-06-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00861172. Inclusion in this directory is not an endorsement.