A Japanese, Multicenter, Open label, Phase 3 Study to Investigate the Safety and Efficacy of Gadobutrol for Contrast enhanced MR Imaging of the Central Nervous System
Purpose: Gadobutrol 1.0 M is macrocyclic gadolinium based contrast agent for magnetic resonance imaging (MRI) This multicenter, open label, phase 3 study aimed to investigate the efficacy and safety of gadobutrol enhanced versus unenhanced MRI in the visualization and diagnosis of central nervous system (CNS) lesions in Japanese patients. Methods: A total of 223 patients referred for contrast enhanced MRI of the CNS underwent unenhanced and gadobutrol enhanced (0.1 mmol/kg body weight) MRI. The unenhanced and combined (unenhanced and enhanced) images were evaluated by three independent readers in a blinded manner for degree of contrast enhancement, border delineation, internal morphology, and number of detected lesions (primary variables) and for primary diagnosis and diagnostic confidence. Final clinical diagnoses were established by an independent truth committee consisting of two neurosurgeons. Sensitivity, specificity, and accuracy were calculated for the detection of malignancy and the preciseness of diagnoses (secondary variables) by comparing the results obtained by the blinded readers and the truth committee. Results: Gadobutrol enhancement significantly improved three visualization parameters in MR images: contrast enhancement, border delineation, and internal morphology (P 0.0001) Non inferiority was achieved for mean number of lesions detected. Gadobutrol enhanced imaging provided significant improvements in sensitivity and accuracy for the detection of malignant disease with no loss in specificity, and also improvements in accuracy of exact match diagnosis and diagnostic confidence. Drug related adverse events were reported in 6 out of 223 patients (2.7% all were non serious. Conclusion: Gadobutrol is an effective and well tolerated contrast agent for MR imaging of the CNS.
Magnetic resonance in medical sciences MRMS an official journal of Japan Society of Magnetic Resonance in Medicine