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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

Journal of Computer Assisted Tomography: March-April 2010 - Volume 34 - Issue 2 - p 163-172
doi: 10.1097/RCT.0b013e3181c89d87
Abdominal Imaging

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.

From the *Department of Radiological Sciences, UCLA, Los Angeles, CA; †Hartford Hospital, Hartford, CT; ‡The Johns Hopkins University School of Medicine, Baltimore, MD; §MRI Center, Miami, FL; ∥Department of Radiology, Massachusetts General Hospital; ¶Department of Radiology, Brigham and Women's Hospital, Boston, MA; #Department of Diagnostic Imaging, Rhode Island Hospital, Providence, RI; **Department of Radiology, University of Arizona Health Sciences Center, Tucson, AZ; ††Department of Radiology, Thomas Jefferson University Hospital, Philadelphia, PA; ‡‡Department of Radiology, Duke University Medical Center, Durham, NC; §§Department of Radiology, Mayo Clinic, Rochester, MN; ∥∥Department of Radiology, University of Michigan Hospitals, Ann Arbor, MI; ¶¶Department of Radiology, University of North Carolina School of Medicine, Chapel Hill, NC; ##Bayer HealthCare Pharmaceuticals, Wayne, NJ; and ***Bayer Schering Pharma AG, Berlin, Germany.

Received for publication January 23, 2009; accepted October 12, 2009.

Reprints: Steven S. Raman, MD, Department of Radiological Sciences, UCLA, 10833 Le Conte Ave, Los Angeles, CA 90095-1721 (e-mail: sraman@mednet.ucla.edu).

Funding of this study and its editorial support were received from and sponsored by Bayer Schering Pharma AG, Berlin, Germany.

Dr Leary is now with Bristol Hospital, Bristol, CT.

Dr Amendola is now with the Main Hospital of Virginia Commonwealth University, Richmond, VA.

Dr McTavish is now with the Hampton Roads Radiology Associates, Norfolk, VA.

© 2010 Lippincott Williams & Wilkins, Inc.