Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Phase 3 Completed 260 enrolled Guerbet

RandomizedCrossoverQuadruple-blindDiagnostic

Summary

This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Timeline

Start: 2019-06-03
Primary completion: 2020-09-11
Completion: 2020-09-11

Outcome

Met primary endpoint

registry analysis (superiority test); Patients With Gadopiclenol Paired Images vs Patients With Gadopiclenol Pre Images; p <.0001; Mean Difference (Final Values) 1.82 (95% CI 1.76 to 1.88); NCT03996447 ↗

Publications

Results Loevner LA, Kolumban B, Hutoczki G, Dziadziuszko K, Bereczki D, Bago A, Pichiecchio A. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. Invest Radiol. 2023 May 1;58(5):307-313. doi: 10.1097/RLI.0000000000000944. Epub 2022 Dec 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gadobutrol	Diagnostic / imaging agent	—	Intravenous
Subject	Gadopiclenol	Diagnostic / imaging agent	—	Intravenous

Indications

No indication recorded.