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

Phase 3

Completed

• Conditions: Magnetic Resonance Imaging
• Interventions: Drug: Gadobutrol (Gadovist, BAY86-4875)

• Registration Number: NCT01660841
• Lead Sponsor: Bayer

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-09
• Study Start: 2012-09
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-30
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Gadobutrol (Gadovist, BAY86-4875)	-

Primary Outcome Measures

Name	Time	Method
Scores for visualization parameter: border delineation	Day of gadobutrol injection (Day 0)	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	Day of gadobutrol injection (Day 0)	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.
Scores for visualization parameter: degree of contrast enhancement	Day of gadobutrol injection (Day 0)	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.
Number of detected lesions	Day of gadobutrol injection (Day 0)	Blinded readers determine number of detected lesions in scans with and without gadobutrol.

Secondary Outcome Measures

Name	Time	Method
Percentage of exact match of the MRI diagnosis with the final clinical diagnosis	Day of gadobutrol injection (Day 0)	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	Day of gadobutrol injection (Day 0)	Blinded readers classify the brain tissue as normal or abnormal based on the MRI sets.
Number of participants with treatment emergent adverse events as a measure of safety and tolerability	3 days after injection (Day 3)
Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions	Day of gadobutrol injection (Day 0)	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.