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

doi:10.1097/RCT.0b013e3181c89d87

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

Radiology

Research output: Contribution to journal › Article › peer-review

51 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 language	English (US)
Pages (from-to)	163-172
Number of pages	10
Journal	Journal of computer assisted tomography
Volume	34
Issue number	2
DOIs	https://doi.org/10.1097/RCT.0b013e3181c89d87
State	Published - 2010

Keywords

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

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging

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10.1097/RCT.0b013e3181c89d87

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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

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.; Leary, Christopher; Bluemke, David A. et al.
In: Journal of computer assisted tomography, Vol. 34, No. 2, 2010, p. 163-172.

Research output: Contribution to journal › Article › peer-review

Raman, SS, Leary, C, Bluemke, DA, Amendola, M, Sahani, D, McTavish, JD, Brody, J, Outwater, E, Mitchell, D, Sheafor, DH, Fidler, J, Francis, IR, Semelka, RC, Shamsi, K, Gschwend, S, Feldman, DR & 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, vol. 34, no. 2, pp. 163-172. https://doi.org/10.1097/RCT.0b013e3181c89d87

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

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.",

keywords = "Computed tomography, Contrast agent, Gd-EOB-DTPA, Liver lesion, Magnetic resonance",

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

year = "2010",

doi = "10.1097/RCT.0b013e3181c89d87",

language = "English (US)",

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T1 - Improved characterization of focal liver lesions with liver-specific gadoxetic acid disodium-enhanced magnetic resonance imaging

T2 - A multicenter phase 3 clinical trial

AU - Raman, Steven S.

AU - Leary, Christopher

AU - Bluemke, David A.

AU - Amendola, Marco

AU - Sahani, Dushyant

AU - McTavish, Jeffrey D.

AU - Brody, Jeffrey

AU - Outwater, Eric

AU - Mitchell, Donald

AU - Sheafor, Douglas H.

AU - Fidler, Jeff

AU - Francis, Isaac R.

AU - Semelka, Richard C.

AU - Shamsi, Kohkan

AU - Gschwend, Simone

AU - Feldman, David R.

AU - Breuer, Josy

PY - 2010

Y1 - 2010

N2 - 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.

AB - 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.

KW - Computed tomography

KW - Contrast agent

KW - Gd-EOB-DTPA

KW - Liver lesion

KW - Magnetic resonance

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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

Abstract

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