This double-blind randomized cross-over study was conducted to demonstrate non-inferiority of gadoterate meglumine vs. gadobutrol in MRI diagnosis of brain tumors. Images from two identical MRIs with each agent were evaluated by three independent off-site readers. Overall lesion visualization and characterization was scored as “good” or “excellent” in >90% of patients by all readers. Despite a small difference in signal intensity measurements in favor of gadobutrol, similar results were observed with the two agents regarding overall lesion visualization and characterization or qualitative efficacy criteria. Non-inferiority of gadoterate meglumine vs. gadobutrol in diagnosis of brain tumors by MRI was demonstrated.