International, Multicenter Phase 3 Blinded Study of the Structural Visualization, Diagnostic Efficacy and Safety of Gadobutrol (Gadavist) Enhanced MRA of the Renal Arteries compared to Time-of-Flight MRA using CTA as the standard of reference (SoR)
Jacob Agris1, Neda Rastegar2, Kelly Fabrega-Foster2, Sheela Agarwal1,3, Daniel Haverstock4, and Ihab Kamel2
1Radiology, Bayer, Whippany, NJ, United States, 2Radiology, Johns Hopkins, Baltimore, MD, United States, 3Radiology, Massachusetts General Hospital, Boston, MA, United States, 4Statistics, Bayer, Whippany, NJ, United States
International, multicenter phase 3 blinded study comparing
the performance of CE-MRA with Gadobutrol, a high relaxivity and highly stable
macrocyclic contrast agent, to 2D Time-of-flight MRA (ToF) using CTA as the
standard of reference (SoR). 317 patients suspected of renal artery disease were
enrolled. There was almost no error in the Gadobutrol MRA vessel measurements
(0.0mm Gadobutrol vs 0.5mm ToF for stenosis measurements) and superior
assessability as well as superior specificity was demonstrated reducing the need for additional
imaging studies by 50%. Gadobutrol enhanced MRA of the renal arteries has
superior visualization, more accurate measurements and is a valuable
alternative to CTA without any ionizing radiation.
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