Phase III clinical studies with gadoteridol for the evaluation of neurologic pathology. A European perspective.
OBJECTIVE
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.
Seiderer
M
M
Department of Radiology, University of Munich, Klinikum Grosshadern, Germany.
D001921:Brain / Q000473:pathology; D001927:Brain Diseases / Q000175:diagnosis; D002986:Clinical Trials as Topic; D003287:Contrast Media / Q000009:adverse effects; D005682:Gadolinium / Q000009:adverse effects; D006571:Heterocyclic Compounds / Q000009:adverse effects; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods; D009422:Nervous System Diseases / Q000175:diagnosis*; D009942:Organometallic Compounds / Q000009:adverse effects; D013122:Spinal Diseases / Q000175:diagnosis; D013131:Spine / Q000473:pathology
D003287:Contrast Media; D006571:Heterocyclic Compounds; D009942:Organometallic Compounds; C062402:gadoteridol; D005682:Gadolinium