Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries

Phase 3 Completed 120 enrolled Bracco Diagnostics, Inc

RandomizedCrossoverTriple-blindDiagnostic

Summary

To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries

Timeline

Start: 2009-09
Primary completion: 2011-12
Completion: 2011-12

Outcome

Met primary endpoint

paper CONCLUSIONS: The image quality and diagnostic performance achieved with 0.1-mmol/kg gadobenate dimeglumine is at least equivalent to that achieved with 0.2-mmol/kg gadopentetate dimeglumine. PMID 23042922 ↗

Publications

Li Y, Li X, Li D, Lu J, Xing X, Yan F, Li Y, Wang X, Iezzi R, De Cobelli F. Multicenter, intraindividual comparison of single-dose gadobenate dimeglumine and double-dose gadopentetate dimeglumine for MR angiography of the supra-aortic arteries (the Supra-Aortic VALUE study). AJNR Am J Neuroradiol. 2013 Apr;34(4):847-54. doi: 10.3174/ajnr.A3298. Epub 2012 Oct 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gadobenate dimeglumine	Diagnostic / imaging agent	0.1 unknown	—
Comparator	Gadopentetate dimeglumine	Diagnostic / imaging agent	0.2 unknown	—