This longitudinal study was performed to evaluate and compare a) the numbers of total and new enhancing lesions detected by serial brain magnetic resonance imaging (MRI) scans after the injection of a standard (SD) anJ a triple dose (TD) of gadolinium-DTPA (Gd) in patients with multiple sclerosis (MS); b) the contribution of scanning delay to MRI sensitivity; c) the sample sizes needed to perform clinical trials using the numbers of enhancing lesions detected by SD and TD as outcome measure and d) the safety of the serial administration of the TD of Gd.SD and TD enhanced MRI scans were obtained in two separate sessions in 45 patients every 4 weeks for 3 months. Enhanced scans were obtained 5 minutes (early) and 20 minutes (delayed) after Gd injection. A single observer, unaware of Gd dosage and time of scanning, counted the number of total and new enhancing lesions.The total numbers of enhancing lesions were 435 (new=242) on the early SD , 479 (new=263) on the delayed SD, 772 (new=365) on the early TD and 827 (new=404) on the delayed TD scans. Statistical simulations indicated that the total number of scans needed to perform both parallel group or cross over clinical trials is about 1/3 lower when TD MRI is used. No side effects were reported. No significant changes in blood test parameters were found during the follow up. Our results indicate that the serial use of TD is safe and that it increases significantly the numbers of brain enhancing lesions detected in patients with MS when serial MRI scanning is performed.
|Number of pages||1|
|Journal||Italian Journal of Neurological Sciences|
|Publication status||Published - 1997|
ASJC Scopus subject areas
- Clinical Neurology