Brain, Vol 121, Issue 10 2011-2020, Copyright © 1998 by Oxford University Press
M Filippi, M Rovaris, R Capra, C Gasperini, TA Yousry, MP Sormani, F Prandini, MA Horsfield, V Martinelli, S Bastianello, I Kuhne, C Pozzilli and G Comi
In this study we assessed the safety, efficacy and cost-effectiveness of
the use of triple dose gadolinium-DTPA (Gd) in serial monthly brain MRI of
patients with multiple sclerosis, such as could be selected for clinical
trials. The number of enhancing lesions, the number of new enhancing
lesions and the number of active scans were used to evaluate the
sensitivity of the contrast-enhanced MRI to disease activity. The dose of
Gd, and the effect of introducing a delay between the contrast injection
and the scan were both appraised. Every 4 weeks for 3 months, and in two
separate sessions, scans were obtained from 40 patients with
relapsing-remitting or secondary progressive multiple sclerosis, 5 min
(early) and 20 min (delayed) after a standard dose (0.1 mmol/kg) or triple
dose (0.3 mmol/kg) Gd injection. There were 435 enhancing lesions (242 of
which were new) on the early standard dose scans, 479 (263 new) on the
delayed standard dose, 772 (365 new) on the early triple dose and 827 (404
new) on the delayed triple dose. There were 109 scans revealing active
disease on the early standard dose scans, 112 on the delayed standard dose,
119 on the early triple dose and 120 on the delayed triple dose.
Statistical simulations indicated that the sample sizes needed for both
cross-over and parallel-group trials with similar powers are lower if
serial monthly triple dose MRI is used. No side-effects were reported and
no significant changes in blood test parameters were found throughout the
study. This study shows that the serial use of triple dose Gd is safe, and
that it increases the sensitivity of serial monthly enhanced MRI in
detecting multiple sclerosis activity significantly. Its use should enable
preliminary trials of experimental therapies for multiple sclerosis to be
conducted in small patient populations, over a short period of time.
REVIEWS
A multi-centre longitudinal study comparing the sensitivity of monthly MRI after standard and triple dose gadolinium-DTPA for monitoring disease activity in multiple sclerosis. Implications for phase II clinical trials
Department of Neuroscience, Scientific Institute, Ospedale San Raffaele, University of Milan, Italy.
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