Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging

Bayer

Status and phase: Completed; Phase 3

Conditions: Central Nervous System Diseases

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00623467

91682

Details and patient eligibility

About

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.

Full description

Issues on safety will be addressed in Adverse Events section.

Enrollment: 343 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients referred for contrast enhanced MRI of the CNS based on symptoms or previous procedures.

Exclusion criteria

• Patients with acute renal insufficiency
• Patients with severe renal disease
• Patients with any contraindication to magnetic resonance imaging.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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343 participants in 1 patient group

Gadobutrol (Gadavist, BAY86-4875)

Experimental group

Description:

Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.

Treatment:

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