A Phase 3 interventional study of Gadobutrol (Gadovist, BAY86-4875) in Magnetic Resonance Imaging, sponsored by Bayer. Completed at 15 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-01.
Sponsored by Bayer · Phase 3, Interventional, and Diagnostic
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).
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Exclusion Criteria:
Drug: Gadobutrol (Gadovist, BAY86-4875)
A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.
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)
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)
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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