Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging

A Multicenter, Open-label, Phase III Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)

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 images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 811-0213
  • Fukuoka, Japan, 810-0001
  • Aichi
    • Nagoya, Aichi, Japan, 455-8530
  • Chiba
    • Funabashi, Chiba, Japan, 274-8503
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 800-0057
  • Hiroshima
    • Fukuyama, Hiroshima, Japan, 720-0825
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0047
    • Kobe, Hyogo, Japan, 654-0047
  • Kanagawa
    • Fujisawa, Kanagawa, Japan, 251-8550
    • Kawasaki, Kanagawa, Japan, 210-0013
    • Yokohama, Kanagawa, Japan, 226-0025
  • Osaka
    • Daito, Osaka, Japan, 574-0074
    • Kishiwada, Osaka, Japan, 596-8522
  • Yamaguchi
    • Shimonoseki, Yamaguchi, Japan, 750-0061
    • Ube, Yamaguchi, Japan, 755-0151

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects referred for a contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system based on current clinical symptoms or results of a previous imaging procedure

Exclusion Criteria:

• Subjects with any contraindication to the MRI examination
• Subjects with severe renal disease to end stage renal disease
• Subjects scheduled or are likely to require a biopsy or any interventional therapeutic procedure within 72 (±4) hours after the study MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: Gadobutrol (Gadovist, BAY86-4875); A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores for visualization parameter: degree of contrast enhancement	Blinded readers evaluate contrast of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.	Day of gadobutrol injection (Day 0)
Scores for visualization parameter: border delineation	Blinded readers evaluate border delineation of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.	Day of gadobutrol injection (Day 0)
Scores for visualization parameter: internal morphology	Blinded readers evaluate internal morphology of at maximum 5 lesions and 4 normal structures in scans taken with and without gadobutrol on a 3-point-scale.	Day of gadobutrol injection (Day 0)
Number of detected lesions	Blinded readers determine number of detected lesions in scans with and without gadobutrol.	Day of gadobutrol injection (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of exact match of the MRI diagnosis with the final clinical diagnosis	An exact match is defined as identical diagnosis given by the blinded reader and the independent standard of truth committee.	Day of gadobutrol injection (Day 0)
Sensitivity and specificity to detect abnormal/normal brain tissue	Blinded readers classify the brain tissue as normal or abnormal based on the MRI sets.	Day of gadobutrol injection (Day 0)
Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions	Percentage to correctly detect presence and absence of malignant lesions which are derived from the MR diagnosis of readers when compared with the diagnosis of the independent standard of truth committee.	Day of gadobutrol injection (Day 0)
Number of participants with treatment emergent adverse events as a measure of safety and tolerability		3 days after injection (Day 3)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: August 7, 2012
• First Posted (Estimate): August 9, 2012

Study Record Updates

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

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; central nervous system; contrast media; gadobutrol
• Other Study ID Numbers: 16260