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

Multiple Sclerosis Clinical Trial

— IRM 3T-SEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861172
• Other study ID #: 2008.532
• Status: Completed
• Phase: N/A
• First received: March 12, 2009
• Last updated: June 20, 2013
• Start date: February 2009
• Est. completion date: July 2012

Study information

• Verified date: June 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lesions
• Multiple Sclerosis
• Sclerosis

Intervention

Procedure:
• 3T 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.

Locations

Country	Name	City	State
France	Services de Neurologie A et Service de Neuroradiologie, Pôle transversal d'imagerie, Hôpital Neurologique	BRON Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Relation between plaques development and cerebral venous structures.		each week for 2 months, at 6 month and at 12 month	No