Efficacy and Safety of Gadobutrol (1.0 M) versus Gadopentetate Dimeglumine (0.5 M) for Enhanced MRI of CNS Lesions: A Phase III, Multicenter, Single-Blind, Randomized Study in Chinese Patients

The aim of this study was to compare the efficacy and safety of macrocyclic gadobutrol (1.0 M) with linear gadopentetate dimeglumine (0.5 M) for contrast-enhanced magnetic resonance imaging (MRI) of central nervous system (CNS) lesions in Chinese patients (N = 147) with known or suspected CNS lesions, who were enrolled in this single-blind, randomized, parallel-group study. Three blinded independent readers evaluated all efficacy variables. The primary efficacy variable was the difference between the two agents for the change in contrast-to-noise ratio (CNR) between non-enhanced and contrast-enhanced scans of lesions. Secondary outcomes included mean change in number of lesions detected before and after contrast enhancement, diagnostic confidence, and safety and tolerability parameters. Gadobutrol was non-inferior to gadopentetate dimeglumine in respect to the difference in the mean change in CNR (6.94; 95% confidence interval [CI] lower limit: -3.90; predefined maximum 95% CI lower limit: -6.52). The mean change in the number of CNS lesions detected was greater with gadobutrol versus gadopentetate dimeglumine (1.2 vs. 0.2 lesions). Diagnostic confidence was classified as ‘high’ for more patients with gadobutrol versus gadopentetate dimeglumine by the investigators (58.8% vs. 55.4%) and by the three blinded readers (63.6% vs. 55.7%, 23.7% vs. 18.0% and 81.7% vs. 81.0%). Both agents were well tolerated by participating patients. We concluded that in Chinese patients with CNS lesions, gadobutrol (1.0 M) was as effective and well tolerated in contrast-enhanced MRI as gadopentetate dimeglumine (0.5 M). Gadobutrol provided improved visualization of CNS lesions compared with gadopentetate dimeglumine, with a comparable tolerability profile.