Gadobutrol Magnevist-controlled Body Study

Inclusion criteria

• Is at least 20 years of age
• Is referred for a contrast-enhanced MRI of the body/extremities based on current clinical symptoms or results of a previous imaging procedure
• Is willing to undergo the routine contrast-enhanced MRI examinations
• Is willing and able to complete all study procedures specified in the protocol
• Subject is male, or is female not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test prior to the administration of gadobutrol or Magnevist

Exclusion criteria

• Is a female subject who is pregnant or nursing
• Has received any investigational product or has participated in any other clinical trial within 2 weeks 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 or the use of Gd-containing contrast agents
• 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 the study MRI
• Has a glomerular filtration rate value <30 mL/min/1.73m2 derived from a serum creatinine result within 4 weeks prior to study enrollment
• Is considered clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure)
• Has severe cardiovascular disease (eg, acute myocardial infarction (<14 days), unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (<48 hours)
• Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period
• Has any contraindication to Magnevist according to the package insert