Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients

A Single-blind, Multicenter, Randomized, Phase III Study of the Efficacy and Safety of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent for Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions in Chinese Patients

The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Inclusion Criteria:

• Chinese origin, with known or suspected brain or spine diseases

Exclusion Criteria:

• Pregnancy
• Lactation
• Conditions interfering with MRI
• Allergy to any contrast agent or any drugs
• Participation in other trial
• Require emergency treatment
• Severely impaired liver and kidney functions