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

Study Overview
=================
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).

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)

Conditions
-----------------
Magnetic Resonance Imaging

Intervention / Treatment
-----------------
* Drug: Gadobutrol (Gadovist, BAY86-4875)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Gadobutrol (Gadovist, BAY86-4875)<br>* A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Day of gadobutrol injection (Day 0) | 
| Number of detected lesions | Blinded readers determine number of detected lesions in scans with and without gadobutrol. | Day of gadobutrol injection (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Day of gadobutrol injection (Day 0) | 
| Number of participants with treatment emergent adverse events as a measure of safety and tolerability |  | 3 days after injection (Day 3) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic resonance imaging, central nervous system, contrast media, gadobutrol