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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01660841
First received: August 7, 2012
Last updated: September 30, 2014
Last verified: September 2014
  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:


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 ]

Enrollment: 223
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01660841     History of Changes
Other Study ID Numbers: 16260
Study First Received: August 7, 2012
Last Updated: September 30, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Gadobutrol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2014