Improved characterization of focal liver lesions with liver-specific gadoxetic acid disodium-enhanced magnetic resonance imaging: a multicenter phase 3 clinical trial.

Authors

• Steven S Raman
• Christopher Leary
• David A Bluemke
• Marco Amendola
• Dushyant Sahani
• Jeffrey D McTavish
• Jeffrey Brody
• Eric Outwater
• Donald Mitchell
• Douglas H Sheafor
• Jeff Fidler
• Isaac R Francis
• Richard C Semelka
• Kohkan Shamsi
• Simone Gschwend
• David R Feldman
• Josy Breuer

Publication/Presentation Date

1-1-2010

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 < or = 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 < or = 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.

Volume

34

Issue

2

First Page

163

Last Page

172

ISSN

1532-3145

Published In/Presented At

Raman, S. S., Leary, C., Bluemke, D. A., Amendola, M., Sahani, D., McTavish, J. D., Brody, J., Outwater, E., Mitchell, D., Sheafor, D. H., Fidler, J., Francis, I. R., Semelka, R. C., Shamsi, K., Gschwend, S., Feldman, D. R., Breuer, J., & United States EOB Study Group (2010). Improved characterization of focal liver lesions with liver-specific gadoxetic acid disodium-enhanced magnetic resonance imaging: a multicenter phase 3 clinical trial. Journal of computer assisted tomography, 34(2), 163–172. https://doi.org/10.1097/RCT.0b013e3181c89d87

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

20351497

Department(s)

Administration and Leadership

Document Type

Article