Multi-center, Double-blind, Randomized, Controlled, Parallel Group, Dose Comparison Study With Corresponding Blinded Image Evaluation Following a Single Intravenous Injection of Three Different Doses of Gadobutrol 1.0 Molar (Gadavist) in Patients With Known or Suspected Focal Blood Brain Barrier Disturbances and/or Abnormal Vascularity of the Central Nervous System

Inclusion Criteria:

- Patients with either known or highly suspected focal areas of disruption of the blood
brain barrier (BBB) (eg, primary and secondary tumors, focal inflammatory or
demyelinating disorders) and/or abnormal vascularity in the CNS, who are scheduled to
undergo a routine contrast-enhanced MRI of the CNS.

- Patients with untreated brain tumors should constitute a minimum of 50% of the study
population and patients with treated brain tumors will be limited to a maximum of 20%
of the study population

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.