check_circleStudy Completed

Magnetic Resonance Imaging

Bayer Identifier:

16260

ClinicalTrials.gov Identifier:

NCT01660841

EudraCT Number:

Not Available

EU CT Number:

Not Available
Safety and efficacy of gadobutrol 1.0 molar in Japanese subjects for CNS imaging

Trial 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).

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
223
Trial Dates
September 2012 - August 2013
Phase
Phase 3
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Chiba Tokushukai HospitalFunabashi, 274-8503, Japan
Completed
Kawasaki Municipal HospitalKawasaki, 210-0013, Japan
Completed
Yokohama Shinmidori General HospitalYokohama, 226-0025, Japan
Completed
Fujisawa City HospitalFujisawa, 251-8550, Japan
Completed
Chubu Rosai HospitalNagoya, 455-8530, Japan
Completed
Nozaki Tokushukai HospitalDaito, 574-0074, Japan
Completed
Kishiwada Tokushukai HospitalKishiwada, 596-8522, Japan
Completed
Institute of Biomedical Research and InnovationKobe, 650-0047, Japan
Completed
Shinsuma HospitalKobe, 654-0047, Japan
Completed
Ube Industries Central HospitalUbe, 755-0151, Japan
Completed
Shimonoseki Kosei HospitalShimonoseki, 750-0061, Japan
Completed
Fukuokaken Saiseikai Fukuoka General HospitalFukuoka, 810-0001, Japan
Completed
Shinkomonji HospitalKitakyushu, 800-0057, Japan
Completed
Fukuoka Wajiro HospitalFukuoka, 811-0213, Japan
Completed
Brain Attack Center Oota Memorial HospitalFukuyama, 720-0825, Japan

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Day of gadobutrol injection (Day 0)
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Day of gadobutrol injection (Day 0)
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Day of gadobutrol injection (Day 0)
    enhanced_encryption
    Safety Issue:
    No
  • Number of detected lesions
    Blinded readers determine number of detected lesions in scans with and without gadobutrol.
    date_rangeTime Frame:
    Day of gadobutrol injection (Day 0)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    Day of gadobutrol injection (Day 0)
    enhanced_encryption
    Safety Issue:
    No
  • Sensitivity and specificity to detect abnormal/normal brain tissue
    Blinded readers classify the brain tissue as normal or abnormal based on the MRI sets.
    date_rangeTime Frame:
    Day of gadobutrol injection (Day 0)
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Day of gadobutrol injection (Day 0)
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with treatment emergent adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    3 days after injection (Day 3)
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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