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

Phase 2 Completed 237 enrolled Bayer

RandomizedParallel-groupTriple-blindDiagnostic

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.

Timeline

Start: 2005-08
Primary completion: 2007-03
Completion: 2007-03

Outcome

Mixed primary results

paper Pair-wise comparisons of a composite score of the four primary variables showed the 0.1 mmol/kg dose to be statistically superior to the 0.03 mmol/kg dose (P = 0.003). PMID 23681501 ↗

registry Mean Difference (Final Values) -0.53 (95% CI -0.90 to 0.79) NCT00862459 ↗

registry Mean Difference (Final Values) 4.74 (95% CI -15.86 to 25.35); confidence interval using t-distribution NCT00862459 ↗

Publications

Breuer J, Gutierrez J, Latchaw R, Lehr R, Sorensen AG. Gadobutrol in the central nervous system at three doses: results from a phase II, randomized, multicenter trial. J Magn Reson Imaging. 2014 Feb;39(2):410-8. doi: 10.1002/jmri.24180. Epub 2013 May 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gadobutrol	Diagnostic / imaging agent	0.03 mmol	Intravenous
Subject	Gadobutrol	Diagnostic / imaging agent	0.1 mmol	Intravenous
Subject	Gadobutrol	Diagnostic / imaging agent	0.3 mmol	Intravenous
Subject	Gadoversetamide	Diagnostic / imaging agent	0.1 mmol	—