Serial contrast-enhanced magnetic resonance imaging in patients with early relapsing-remitting multiple sclerosis: implications for treatment trials.
Serial monthly contrast-enhanced MRIs were performed in 10 early relapsing-remitting patients with multiple sclerosis and 2 patients with chronic progressive disease for a period of 12 to 55 months. MRI was performed at 1.5 T using contiguous 5-mm slices with pre- and postgadolinium-diethylenetriamine pentaacetic acid (Gd-DTPA) T1-weighted and T2-weighted images. New and total number of Gd-DTPA-enhancing lesions were numbered and counted and lesion areas were correlated to an increase of > or = 0.5 in Expanded Disability Status Scale (EDSS) scores. The frequency of enhancing lesions varied from patient to patient; however, there was a correlation between a burst of enhancing lesion number and area above the individual's mean lesion frequency to an increase in EDSS score. A bootstrap analysis of the lesion count was performed to develop a statistical basis for determining population sizes for treatment trials. These results provide a basis for the potential use of contrast-enhanced MRI as a primary outcome measure in phase II treatment trials involving patients with relapsing-remitting MS.
Frank
J A
JA
Laboratory of Diagnostic Radiology Research, National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, MD 20892.
Stone
L A
LA
Smith
M E
ME
Albert
P S
PS
Maloni
H
H
McFarland
H F
HF
D000328:Adult; D001812:Blood-Brain Barrier; D001921:Brain / Q000473:pathology*; D002908:Chronic Disease; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D019786:Gadolinium DTPA; D006801:Humans; D008137:Longitudinal Studies; D008279:Magnetic Resonance Imaging / Q000379:methods* / Q000706:statistics & numerical data; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000145:classification / Q000175:diagnosis* / Q000473:pathology; D009460:Neurologic Examination; D009942:Organometallic Compounds; D004369:Pentetic Acid / Q000031:analogs & derivatives; D012008:Recurrence; D012720:Severity of Illness Index; D016896:Treatment Outcome
D009942:Organometallic Compounds; D004369:Pentetic Acid; D019786:Gadolinium DTPA