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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
223
A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Funabashi, Chiba, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
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.
Time frame: 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.
Time frame: 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.
Time frame: Day of gadobutrol injection (Day 0)
Number of detected lesions
Blinded readers determine number of detected lesions in scans with and without gadobutrol.
Time frame: Day of gadobutrol injection (Day 0)
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.
Time frame: 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.
Time frame: Day of gadobutrol injection (Day 0)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Kitakyushu, Fukuoka, Japan
Unnamed facility
Fukuyama, Hiroshima, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Fujisawa, Kanagawa, Japan
Unnamed facility
Kawasaki, Kanagawa, Japan
...and 5 more locations
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.
Time frame: Day of gadobutrol injection (Day 0)
Number of participants with treatment emergent adverse events as a measure of safety and tolerability
Time frame: 3 days after injection (Day 3)