Conditions: Primary Brain Tumor
Keywords: Primary brain tumor
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 279
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI arm 2: Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI

Interventions: intervention 1: Dotarem® intervention 2: Gadovist®/Gadavist®
Intervention descriptions: intervention 1: Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus. intervention 2: Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.

Protocol document: