Phase III clinical studies with gadoteridol for the evaluation of neurologic pathology. A European perspective.

OBJECTIVES AND RATIONALE

The use of paramagnetic contrast agents has improved the diagnostic sensitivity and specificity of magnetic resonance imaging (MRI) for evaluating diseases of the central nervous system. To assess the safety and imaging properties of the nonionic, gadolinium-based MRI contrast agent gadoteridol, 151 patients and controls were evaluated for safety, and 118 patients with cerebral or spinal pathology were evaluated for imaging efficacy.

METHODS

Precontrast T1- and T2-weighted spin-echo images and postcontrast (0.10 mmol/kg) T1-weighted spin-echo images were read by unblinded investigators at each site.

RESULTS

The rate of adverse events possibly or probably related to gadoteridol was 4.0% (vasodilation [facial flushing], 1 patient; nausea, 3 patients; urticaria, 2 patients). Laboratory changes were reported in 6.0%. None of these events or changes was considered to be clinically significant. Contrast enhancement was noted in 75% of cases with brain pathology and 64% of cases involving spine lesions.

CONCLUSIONS

Gadoteridol is safe in routine clinical use at a dose of 0.10 mmol/kg and provides improved lesion detection compared to plain MRI.