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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Magnetic Resonance Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Gadobutrol (Gadovist, BAY86-4875)

Intervention Type DRUG

A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.

Interventions

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Gadobutrol (Gadovist, BAY86-4875)

A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No