Conditions: Central Nervous System Diseases
Keywords: Central Nervous System Imaging Diagnostic Imaging
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 343
Healthy volunteers: no

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

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

Arms:
arm 1: Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.

Interventions: intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention descriptions: intervention 1: Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.

Protocol document: