Abstract #2676

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 Agarwal^1,3, 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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