Conditions: Brain Disease
Keywords: confirmed brain disease highly suspected brain disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 179
Healthy volunteers: no

Brief summary:
This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of MultiHance.

Detailed description:
This crossover study aims at a comparison between 0.1 mmol/kg MultiHance and 0.1 mmol/kg Dotarem, between 0.05 MultiHance and 0.1 mmol/kg Dotarem in terms of diagnostic preference at CE-MRI in brain tumor patients to show superiority of MultiHance.

Arms:
arm 1: MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg arm 2: MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg arm 3: Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg arm 4: Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg

Interventions: intervention 1: MultiHance 0.1 mmol/kg intervention 2: Dotarem intervention 3: MultiHance 0.05 mmol/kg
Intervention descriptions: intervention 1: MultiHance administered at 0.1 mmol/kg intervention 2: Dotarem administered at 0.1 mmol/kg intervention 3: MultiHance administered at 0.05 mmol/kg

Protocol document: