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

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

Research output: Contribution to journalArticle

50 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)163-172
Number of pages10
JournalJournal of computer assisted tomography
Volume34
Issue number2
DOIs
StatePublished - Mar 2010

Keywords

  • Computed tomography
  • Contrast agent
  • Gd-EOB-DTPA
  • Liver lesion
  • Magnetic resonance

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Fingerprint Dive into the research topics of 'Improved characterization of focal liver lesions with liver-specific gadoxetic acid disodium-enhanced magnetic resonance imaging: A multicenter phase 3 clinical trial'. Together they form a unique fingerprint.

  • Cite this

    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. (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