Conditions: Brain Disease
Keywords: Have confirmed or are highly suspected of brain disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 229
Healthy volunteers: no

Brief summary:
This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.

Detailed description:
Adult patients were given two MRI exams, one after injection of ProHance (0.1 mmol/kg) and one after injection of Gadovist/Gadavist (0.1 mmol/kg). The exams were performed with identical equipment and imaging parameters with the order of the two exams randomized and 2-14 days between the first and the second MRI exam. Image data was evaluated by 3 expert neuroradiologist blinded to the agent administered and patient clinical data.

Arms:
arm 1: MRI after 0.1 mmol/kg IV ProHance, then with 0.1 mmol/kg Gadovist/Gadavist. MRI performed after both agents with identical sequences. arm 2: MRI after 0.1 mmol/kg IV Gadovist/Gadavist, then with 0.1 mmol/kg ProHance. MRI performed after both agents with identical sequences.

Interventions: intervention 1: gadoteridol intervention 2: gadobutrol
Intervention descriptions: intervention 1: ProHance 0.1 mmol/kg intervention 2: Gadovist/Gadavist 0.1 mmol/kg

Protocol document: