Conditions: Diagnostic Imaging Central Nervous System Diseases
Keywords: Patients referred for a contrast-enhanced MRI of the CNS CNS Imaging
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 402
Healthy volunteers: no

Brief summary:
This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.

Detailed description:
Issues on safety will be addressed in Adverse Events section.

Arms:
arm 1: Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2. arm 2: Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.

Interventions: intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadoteridol (ProHance)
Intervention descriptions: intervention 1: Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) intervention 2: Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.

Protocol document: