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

This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01660841
First received: August 7, 2012
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Magnetic Resonance Imaging
 Drug: Gadobutrol (Gadovist, BAY86-4875)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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)

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
Drug Information available for: Gadobutrol
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Scores for visualization parameter: degree of contrast enhancement [ Time Frame: Day of gadobutrol injection (Day 0) ] [ Designated as safety issue: No ]
    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.

  • Scores for visualization parameter: border delineation [ Time Frame: Day of gadobutrol injection (Day 0) ] [ Designated as safety issue: No ]
    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.

  • Scores for visualization parameter: internal morphology [ Time Frame: Day of gadobutrol injection (Day 0) ] [ Designated as safety issue: No ]
    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.

  • Number of detected lesions [ Time Frame: Day of gadobutrol injection (Day 0) ] [ Designated as safety issue: No ]
    Blinded readers determine number of detected lesions in scans with and without gadobutrol.


Secondary Outcome Measures:
  • Percentage of exact match of the MRI diagnosis with the final clinical diagnosis [ Time Frame: Day of gadobutrol injection (Day 0) ] [ Designated as safety issue: No ]
    An exact match is defined as identical diagnosis given by the blinded reader and the independent standard of truth committee.

  • Sensitivity and specificity to detect abnormal/normal brain tissue [ Time Frame: Day of gadobutrol injection (Day 0) ] [ Designated as safety issue: No ]
    Blinded readers classify the brain tissue as normal or abnormal based on the MRI sets.

  • Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions [ Time Frame: Day of gadobutrol injection (Day 0) ] [ Designated as safety issue: No ]
    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.

  • Number of participants with treatment emergent adverse events as a measure of safety and tolerability [ Time Frame: 3 days after injection (Day 3) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 220
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Gadobutrol (Gadovist, BAY86-4875)
A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660841

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Japan
Recruiting
Nagoya, Aichi, Japan, 455-8530
Recruiting
Funabashi, Chiba, Japan, 274-8503
Recruiting
Kitakyushu, Fukuoka, Japan, 800-0057
Recruiting
Fukuyama, Hiroshima, Japan, 720-0825
Recruiting
Kobe, Hyogo, Japan, 654-0047
Recruiting
Kobe, Hyogo, Japan, 650-0047
Recruiting
Fujisawa, Kanagawa, Japan, 251-8550
Recruiting
Kawasaki, Kanagawa, Japan, 210-0013
Recruiting
Yokohama, Kanagawa, Japan, 226-0025
Recruiting
Daito, Osaka, Japan, 574-0074
Recruiting
Kishiwada, Osaka, Japan, 596-8522
Recruiting
Shimonoseki, Yamaguchi, Japan, 750-0061
Active, not recruiting
Ube, Yamaguchi, Japan, 755-0151
Recruiting
Fukuoka, Japan, 811-0213
Recruiting
Fukuoka, Japan, 810-0001
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier: NCT01660841     History of Changes
Other Study ID Numbers: 16260
Study First Received: August 7, 2012
Last Updated: April 29, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Magnetic resonance imaging
central nervous system
contrast media
gadobutrol

ClinicalTrials.gov processed this record on May 16, 2013