NCT00862459

Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Multi-center, Double-blind, Randomized, Controlled, Parallel Group, Dose Comparison Study With Corresponding Blinded Image Evaluation Following a Single Intravenous Injection of Three Different Doses of Gadobutrol 1.0 Molar (Gadavist) in Patients With Known or Suspected Focal Blood Brain Barrier Disturbances and/or Abnormal Vascularity of the Central Nervous System

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.

Detailed description

Safety issues are addressed in the Adverse Events section

Conditions

• Brain Diseases
• Spinal Cord Diseases

Interventions

Type	Name	Description
DRUG	Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)	Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
DRUG	Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)	Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
DRUG	Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)	Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
DRUG	OptiMARK~0.1 mmol/kg BW	Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2009-03-17
• Last updated: 2014-01-13
• Results posted: 2012-01-30

Locations

27 sites across 4 countries: United States, Argentina, Brazil, Colombia