Gadobutrol Magnevist-controlled Body Study

Bayer

Status and phase

Completed

Phase 3

Conditions

Magnetic Resonance Imaging

Treatments

Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882)

Drug: Gadobutrol (Gadovist, BAY86-4875)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01050829

13297

Details and patient eligibility

About

The purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the body/extremities regions. The results of the MRI with gadobutrol injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with Magnevist.

Enrollment

370 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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