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Journal of Computer Assisted Tomography:
doi: 10.1097/RCT.0b013e3181c89d87
Abdominal Imaging

Improved Characterization of Focal Liver Lesions With Liver-Specific Gadoxetic Acid Disodium-Enhanced Magnetic Resonance Imaging: A Multicenter Phase 3 Clinical Trial

Raman, Steven S. MD*; Leary, Christopher MD†; Bluemke, David A. MD‡; Amendola, Marco MD§; Sahani, Dushyant MD∥; McTavish, Jeffrey D. MD¶; Brody, Jeffrey MD#; Outwater, Eric MD**; Mitchell, Donald MD††; Sheafor, Douglas H. MD‡‡; Fidler, Jeff MD§§; Francis, Isaac R. MD∥∥; Semelka, Richard C. MD¶¶; Shamsi, Kohkan MD, PhD##; Gschwend, Simone MD, PhD***; Feldman, David R. MD##; Breuer, Josy MD***; United States EOB Study Group

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Abstract

Objectives: To evaluate the safety of gadoxetic acid disodium (Gd-EOB-DTPA) magnetic resonance imaging (MRI) and its efficacy in characterizing liver lesions.

Methods: Lesion characterization and classification using combined (unenhanced and Gd-EOB-DTPA-enhanced) MRI were compared with those using unenhanced MRI and contrast-enhanced spiral computed tomography (CT) using on-site clinical and off-site blinded evaluations for patients with focal liver lesions.

Results: Gadoxetic acid disodium was well tolerated in this study. For the clinical evaluation, more lesions were correctly characterized using combined (unenhanced and Gd-EOB-DTPA-enhanced) MRI than using unenhanced MRI and spiral CT (96% vs 84% and 85%, respectively; P ≤ 0.0008). For the blinded evaluation, more lesions were correctly characterized using combined MRI compared with using unenhanced MRI (61%-76% vs 48%-65%, respectively; P ≤ 0.0012 for 2/3 readers); when compared with spiral CT, a similar proportion of lesions were correctly characterized.

Conclusions: Gadoxetic acid disodium-enhanced MRI is of clinical benefit relative to unenhanced MRI and spiral CT for a radiological diagnosis of liver lesions.

© 2010 Lippincott Williams & Wilkins, Inc.

  

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