Book contents
- Multiple Sclerosis Therapeutics
- Multiple Sclerosis Therapeutics
- Copyright page
- Contents
- Contributors
- Abbreviations list
- Foreword
- Preface
- Section I Introduction
- Section II Clinical trial methodology
- 6 Measures of neurological impairment and disability in multiple sclerosis
- 7 Assessment of neuropsychological function in multiple sclerosis
- 8 Health-related quality of life assessment in multiple sclerosis
- 9 Measures of acute and chronic lesions visualized by conventional magnetic resonance imaging
- 10 Measures of magnetization transfer
- 11 Measurement of CNS atrophy
- 12 Axonal pathology in patients with multiple sclerosis
- 13 Imaging of gray matter lesions in multiple sclerosis
- 14 Functional imaging in multiple sclerosis
- 15 Diffusion imaging in multiple sclerosis
- 16 The use of MRI in multiple sclerosis clinical trials
- 17 Optical coherence tomography to monitor axonal and neuronal integrity in multiple sclerosis
- 18 The process of drug development and approval in the United States, the European Union, and Asia
- 19 Selection, interpretation, and development of end-points for multiple sclerosis clinical trials
- 20 The challenge of demonstrating long-term benefit of disease-modifying therapies in multiple sclerosis
- 21 The growing need for alternative clinical trial designs for multiple sclerosis
- 22 Ethical considerations in multiple sclerosis clinical trials
- 23 Pharmacogenomics and related discovery-driven approaches in multiple sclerosis
- 24 Neutralizing antibodies directed against biologic agents to treat multiple sclerosis
- Section III Clinical trials of multiple sclerosis therapies
- Section IV Therapy in clinical practice
- Index
- Plate Section
16 - The use of MRI in multiple sclerosis clinical trials
from Section II - Clinical trial methodology
Published online by Cambridge University Press: 05 December 2011
Book contents
- Multiple Sclerosis Therapeutics
- Multiple Sclerosis Therapeutics
- Copyright page
- Contents
- Contributors
- Abbreviations list
- Foreword
- Preface
- Section I Introduction
- Section II Clinical trial methodology
- 6 Measures of neurological impairment and disability in multiple sclerosis
- 7 Assessment of neuropsychological function in multiple sclerosis
- 8 Health-related quality of life assessment in multiple sclerosis
- 9 Measures of acute and chronic lesions visualized by conventional magnetic resonance imaging
- 10 Measures of magnetization transfer
- 11 Measurement of CNS atrophy
- 12 Axonal pathology in patients with multiple sclerosis
- 13 Imaging of gray matter lesions in multiple sclerosis
- 14 Functional imaging in multiple sclerosis
- 15 Diffusion imaging in multiple sclerosis
- 16 The use of MRI in multiple sclerosis clinical trials
- 17 Optical coherence tomography to monitor axonal and neuronal integrity in multiple sclerosis
- 18 The process of drug development and approval in the United States, the European Union, and Asia
- 19 Selection, interpretation, and development of end-points for multiple sclerosis clinical trials
- 20 The challenge of demonstrating long-term benefit of disease-modifying therapies in multiple sclerosis
- 21 The growing need for alternative clinical trial designs for multiple sclerosis
- 22 Ethical considerations in multiple sclerosis clinical trials
- 23 Pharmacogenomics and related discovery-driven approaches in multiple sclerosis
- 24 Neutralizing antibodies directed against biologic agents to treat multiple sclerosis
- Section III Clinical trials of multiple sclerosis therapies
- Section IV Therapy in clinical practice
- Index
- Plate Section
Summary
Lesions that are hyperintense on T1 images after intravenous administration of gadolinium chelate represent focal areas of blood-brain barrier (BBB) disruption, which in multiple sclerosis (MS) are presumed to represent areas of active inflammation. T2 lesion burden early in the disease is the best known magnetic resonance imaging (MRI) predictor of long-term disability and brain atrophy. Several imaging approaches have been proposed to provide additional pathologic specificity with greater ability to monitor tissue integrity both within lesions visible on standard imaging, normal appearing brain tissue (NABT), and gray matter (GM). Phase 1 trials aim to expose a relatively small number of subjects to a new medication for a short period of time, monitoring primarily for safety concerns. MRI-based studies have become standard for Phase 2 (proof-of-concept) trials of disease modification in MS. Primary outcomes for Phase 3 (pivotal) trials remain relapses and disability progression.
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- Multiple Sclerosis Therapeutics , pp. 198 - 212Publisher: Cambridge University PressPrint publication year: 2011