Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI)

Exclusion Criteria

• •is a female patient who is pregnant or lactating
• •has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
• •has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
• •has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction \[\< 14 days\], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (\< 48 hours)).
• •has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate \< 60 mL/min/1.73m\^2).
• •has received chemotherapy or hormonal therapy for breast cancer within 6 months.
• •has received hormone replacement therapy within 4 weeks prior to study drug administration.
• •is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
• •has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM