Brain Diseases

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.