Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose

Summary

The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images. The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.

Timeline

Start

2018-11-14

Primary completion

2020-03-13

Completion

2020-05-26

Outcome

Met primary endpoint

paper was noninferior to improvement of standard-dose gadoterate over unenhanced images using a 20% noninferiority margin for all three primary efficacy measures using mean readings (p ≤ .025). PMID 34133205 ↗

registry analysis (non-inferiority test); Gadoterate 0.1 mmol/kg BW vs Gadobutrol 0.075 mmol/kg BW; p < 0.0001 NCT03602339 ↗

registry analysis (non-inferiority test); Gadoterate 0.1 mmol/kg BW vs Gadobutrol 0.075 mmol/kg BW; p = 0.0151 NCT03602339 ↗

registry analysis (non-inferiority test); Gadoterate 0.1 mmol/kg BW vs Gadobutrol 0.075 mmol/kg BW; p = 0.0100 NCT03602339 ↗

release “The Phase IV, multicenter, controlled, cross-over study LEADER-75 with corresponding blinded image evaluations met its primary endpoint” bayer.com ↗

release “showing that a 75 percent dose of gadobutrol (0.075 mmol/kg) is non-inferior to a 100 percent dose of gadoterate (0.1 mmol/kg) for CNS imaging.” bayer.com ↗

Publications

• Liu BP, Rosenberg M, Saverio P, Weon YC, Peters S, Ardellier FD, Boeckenhoff A, Endrikat J. Clinical Efficacy of Reduced-Dose Gadobutrol Versus Standard-Dose Gadoterate for Contrast-Enhanced MRI of the CNS: An International Multicenter Prospective Crossover Trial (LEADER-75). AJR Am J Roentgenol. 2021 Nov;217(5):1195-1205. doi: 10.2214/AJR.21.25924. Epub 2021 Jun 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gadobutrol	Diagnostic / imaging agent	0.075 mmol	Intravenous
Subject	Gadoterate	Diagnostic / imaging agent	0.1 mmol	Intravenous

Indications

No indication recorded.