Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Exclusion Criteria

• •Is a female patient who is pregnant or nursing.
• •Is a female of childbearing potential and did not have a negative urine pregnancy test the same day as the administration of gadobutrol or comparator treatment.
• •Has received any investigational product within 30 days prior to enrolling in this study.
• •Has been previously enrolled in this study or any other study using gadobutrol.
• •Has any contraindication to the MRI examinations.
• •Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents.
• •Has received any contrast agent within 24 hours prior to gadobutrol contrast administration, or is scheduled to receive any contrast agent within 72 hours after the gadobutrol study.
• •Is considered to be clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure).
• •Has been treated with high dose (\>55 cobalt Gy equivalent) photon radiation or global radiotherapy for CNS lesions at any time before entering the study.
• •Is scheduled to receive chemotherapy or radiotherapy during the study period.
• •Is expected or scheduled to have a change in any treatment or procedure between the comparator and gadobutrol MRIs that may alter their interpretation.
• •Is scheduled or is likely to require a biopsy or surgery within the 72 hours after the gadobutrol MRI procedure, or is scheduled for or has undergone such interventions between the comparator and gadobutrol studies.
• •Has severe cardiovascular disease.
• •Has any contraindication to OptiMARK according to the package insert.
• •Has more than 30 brain lesions detected by any prior imaging examination.