SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study

Phase 3 Completed 165 enrolled Bayer

RandomizedCrossoverSingle-blindDiagnostic

Summary

This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.

Timeline

Start: 2007-08
Primary completion: 2008-08
Completion: 2008-08

Outcome

Met primary endpoint

paper Noninferiority of gadobutrol (both doses) to gadoteridol 0.2 mmol/kg BW was demonstrated. PMID 21467949 ↗

Publications

Results Katakami N, Inaba Y, Sugata S, Tsurusaki M, Itoh T, Machida T, Tanaka H, Nakayama T, Morikawa T, Breuer J, Aitoku Y. Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase ii/iii study in patients with known or suspected brain metastases. Invest Radiol. 2011 Jul;46(7):411-8. doi: 10.1097/RLI.0b013e3182145a6c.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gadobutrol	Diagnostic / imaging agent	0.1 unknown	Intravenous
Subject	Gadobutrol	Diagnostic / imaging agent	0.2 unknown	Intravenous
Subject	Gadoteridol	Diagnostic / imaging agent	0.2 unknown	Intravenous