A Multi-center/Multi-national, Randomized, Controlled, Single-blind, Group Comparison Phase 3 Study to Determine the Efficacy and Safety of Gadobutrol 1.0 Molar in Comparison to Magnevist Following Single Injection in Patients Referred for Contrast-enhanced MRI of the Body/Extremities Regions (Breast, Heart, Abdomen, Kidney, Pelvis, or Extremities)
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