title: Guidelines for using quantitative measures of brain magnetic resonance imaging abnormalities in monitoring the treatment of multiple sclerosis.
abstract: The change of brain lesion load, measured on T2-weighted magnetic resonance imaging (MRI) using computer-assisted techniques, is a widely used secondary endpoint for phase III clinical trials in multiple sclerosis (MS). Collection, transfer, and analysis of the electronic data across multiple centers have all proved challenging and give rise to potential errors. However, many new acquisition schemes and postprocessing techniques have been developed; these may reduce scan times and result in better lesion conspicuity or lessen the human interaction needed for data analysis. This review considers many aspects of the use of MRI in clinical trials for MS and provides international consensus guidelines, derived from a task force of the European Magnetic Resonance Networks in Multiple Sclerosis (MAGNIMS) together with a group of North American experts. The main points considered are the organization of correctly powered trials and selection of participating sites; the appropriate choice of pulse sequences and image acquisition protocol given the current state of technology; quality assurance for data acquisition and analysis; accuracy and reproducibility of lesion load assessments; and the potential for the application of quantitative methods to other MRI-derived measures of disease burden.
authors.affiliation: MS Biosignal Analysis Center, Department of Neurology, Scientific Institute Ospedale San Raffaele, University of Milan, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Filippi
authors.forename: M A
authors.initials: MA
authors.lastname: Horsfield
authors.forename: H J
authors.initials: HJ
authors.lastname: Adèr
authors.forename: F
authors.initials: F
authors.lastname: Barkhof
authors.forename: P
authors.initials: P
authors.lastname: Bruzzi
authors.forename: A
authors.initials: A
authors.lastname: Evans
authors.forename: J A
authors.initials: JA
authors.lastname: Frank
authors.forename: R I
authors.initials: RI
authors.lastname: Grossman
authors.forename: H F
authors.initials: HF
authors.lastname: McFarland
authors.forename: P
authors.initials: P
authors.lastname: Molyneux
authors.forename: D W
authors.initials: DW
authors.lastname: Paty
authors.forename: J
authors.initials: J
authors.lastname: Simon
authors.forename: P S
authors.initials: PS
authors.lastname: Tofts
authors.forename: J S
authors.initials: JS
authors.lastname: Wolinsky
authors.forename: D H
authors.initials: DH
authors.lastname: Miller
mesh_terms: D001921:Brain / Q000473:pathology*; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods / Q000592:standards*; D008991:Monitoring, Physiologic / Q000379:methods / Q000592:standards; D009103:Multiple Sclerosis / Q000473:pathology* / Q000628:therapy*; D017410:Practice Guidelines as Topic; D015203:Reproducibility of Results