Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

NCT03986138 ↗

Phase 3 Completed 324 enrolled Guerbet

RandomizedCrossoverQuadruple-blindDiagnostic

Summary

The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)

Timeline

Start: 2019-08-27
Primary completion: 2020-12-09
Completion: 2020-12-09

Outcome

Met primary endpoint

registry analysis (superiority test); Patients With Gadopiclenol Paired Images vs Patients With Gadopiclenol Pre Images; p < 0.0001; Mean Difference (Final Values) 1.53 NCT03986138 ↗

registry analysis (superiority test); Patients With Gadopiclenol Paired Images vs Patients With Gadopiclenol Pre Images; p <0.0001; Mean Difference (Final Values) 0.47 NCT03986138 ↗

Publications

Results Kuhl C, Csoszi T, Piskorski W, Miszalski T, Lee JM, Otto PM. Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. Radiology. 2023 Jul;308(1):e222612. doi: 10.1148/radiol.222612.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gadobutrol	Diagnostic / imaging agent	0.1 unknown	Intravenous
Subject	Gadopiclenol	Diagnostic / imaging agent	0.05 unknown	Intravenous