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

Bayer

Status and phase: Completed; Phase 3

Conditions: Magnetic Resonance Imaging

Treatments: Drug: Gadobutrol (Gadovist, BAY86-4875)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01660841

16260

Details and patient eligibility

About

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).

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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223 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Gadobutrol (Gadovist, BAY86-4875)