Improved Detection of Multiple Sclerosis Plaques in Inversion Recovery by Optimization of Sequence Parameters (FLAIR-SEP)

This study evaluates different optimized MRI sequences for the detection of brain lesions in patients with multiple sclerosis in comparison with the recommended FLAIR sequence

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

Detailed Description

MRI is a tool of choice for detecting demyelinating lesions in Multiple Sclerosis (MS) disease. On a consensual basis, the detection of those lesions in done on FLAIR (FLuid Attenuated Inversion Recovery) sequences, weighted T2 with cancelling of fluid signal, leading to a much better contrast between the lesion and the environment. The environment is displayed as a iso-signal for the surrounding healthy brain's white matter and as a hypo-signal for the fluids. Keys parameters indicative of the sequence's contrast are the echo time, the reversal time, and the repetition time, wich seems to be crucial to detect the lesions, according to relatively discordant results of publications using different technologies of FLAIR. Although 3D FLAIR sequences play an essential role for diagnosis and evaluation (evolution under treatment, prognosis) of demyelinating pathologies there is no consensus on parameters used on routine basis.

The aim of the trial is to discover the optimal combination of theses parameters so as to well detect the lesions.

• Study Type: Observational
• Enrollment (Actual): 27

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with a definite diagnosis of multiple sclerosis, with a follow-up MRI

Description

Inclusion Criteria:

• relapsing remitting multiple sclerosis
• MRI required

Exclusion Criteria:

• MRI contraindication

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of detectable lesions	quantification of lesions on each sequence	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
localisation of lesions	proportion of lesions localised in cerebellum or brainstem, on each sequence	baseline

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2012
• Primary Completion (Actual): July 31, 2013
• Study Completion (Actual): July 31, 2013

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: SC/DM_JSY_2012-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No