Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging

A Multicenter, Open-label, Phase III Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)

Purpose of the 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 images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).

Inclusion Criteria:

• Subjects referred for a contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system based on current clinical symptoms or results of a previous imaging procedure

Exclusion Criteria:

• Subjects with any contraindication to the MRI examination
• Subjects with severe renal disease to end stage renal disease
• Subjects scheduled or are likely to require a biopsy or any interventional therapeutic procedure within 72 (±4) hours after the study MRI