Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors

Summary

The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of overall lesion visualization and characterization (off-site assessment). 270 patients will be randomized between 2 arms defining the sequence of administration of the contrast agents at the dose of 0.1mmol/kg, with a minimum of 48 hours and a maximum of 14 days in between. Each patient will, therefore, receive two MRI during his/her participation in the study. The two arms consist in : * Dotarem® in the first MRI, then Gadovist®/Gadavist® in the second MRI. * Gadovist®/Gadavist® in the first MRI, then Dotarem® in the second MRI. Contrast-enhanced MRIs will be performed on 1.5 or 3 Tesla systems. MRI examinations will be evaluated centrally by blinded independent readers for the main evaluation criterion.

Timeline

Start

2014-06

Primary completion

2015-09

Completion

2015-09

Drugs

Indications