Gadobutrol Magnevist-controlled Body Study

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)

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.

Study Overview

• Status: Completed
• Conditions: Magnetic Resonance Imaging
• Intervention / Treatment: Drug: Gadobutrol (Gadovist, BAY86-4875); Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882)

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100853
  • Shanghai, China, 200032
  • Shanghai, China, 200233
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
    • Suzhou, Jiangsu, China, 215006
  • Shanxi
    • Xi'an, Shanxi, China, 710032
• Japan
  • Fukuoka, Japan, 812-0033
  • Chiba
    • Kamogawa, Chiba, Japan, 296-0041
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
  • Fukuoka
    • Chikushino, Fukuoka, Japan, 818-8516
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0047
  • Shizuoka
    • Sunto, Shizuoka, Japan, 411-8777
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
• Korea, Republic of
  • Seoul, Korea, Republic of, 150-713
  • Seoul, Korea, Republic of, 158-710

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882); Single administration at a dose of 0.1 mmol/kg
Experimental: Arm 1	Drug: Gadobutrol (Gadovist, BAY86-4875); Single administration at a dose of 0.1 mmol/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity for the detection of malignant lesions	At Day 0
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
Confidence in diagnosis	At Day 0

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: January 13, 2010
• First Submitted That Met QC Criteria: January 14, 2010
• First Posted (Estimate): January 15, 2010

Study Record Updates

• Last Update Posted (Estimate): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 26, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Tumor; Gadobutrol; Contrast media
• Other Study ID Numbers: 13297