Gadobutrol Magnevist-controlled Body Study

Magnetic Resonance Imaging Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01050829
• Other study ID #: 13297
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2010
• Last updated: December 26, 2014
• Start date: January 2010
• Est. completion date: April 2011

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationJapan: Pharmaceuticals and Medical Devices AgencyRepublic of Korea: Korean Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

Drug:
• Gadobutrol (Gadovist, BAY86-4875)
Single administration at a dose of 0.1 mmol/kg
• Gadopentetate Dimeglumine (Magnevist, BAY86-4882)
Single administration at a dose of 0.1 mmol/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology.		At Day 0	No
Secondary	Sensitivity and specificity for the detection of malignant lesions		At Day 0	No
Secondary	Exact match of the MR diagnosis with the final clinical diagnosis based on medical records up until 3 months after the scan		At Day 0	No
Secondary	Confidence in diagnosis		At Day 0	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer Healthcare products.