Detection and Characterization of Focal Liver Lesions: A Japanese Phase III, Multicenter Comparison between Gadoxetic Acid Disodium-Enhanced Magnetic Resonance Imaging and Contrast-Enhanced Computed Tomography Predominantly in Patients with Hepatocellular Carcinoma and Chronic Liver Disease

Tomoaki Ichikawa, Kazuhiro Saito, Naoki Yoshioka, Akihiro Tanimoto, Takehiko Gokan, Yasuo Takehara, Takeshi Kamura, Toshifumi Gabata, Takamichi Murakami, Katsuyoshi Ito, Shinji Hirohashi, Akihiro Nishie, Yoko Saito, Hiroaki Onaya, Ryohei Kuwatsuru, Atsuko Morimoto, Koji Ueda, Masayo Kurauchi, Josy Breuer

Research output: Contribution to journalArticle

176 Citations (Scopus)

Abstract

Objectives: To prospectively evaluate the safety and efficacy of combined unenhanced and gadoxetic acid disodium (Gd-EOB-DTPA)-enhanced magnetic resonance (MR) imaging compared with unenhanced MR imaging and triphasic contrast-enhanced spiral computed tomography (CT) for the detection and characterization of focal liver lesions. Materials and Methods: The study was reviewed and approved by the institutional review board at each of the 15 centers involved in the study, and informed written consent was given by all patients. In total, 178 patients with suspected focal hepatic lesions (based, in most patients, on CT, tumor marker and ultrasound examinations) underwent combined MR imaging with a single, rapid injection of Gd-EOB-DTPA 0.025 mmol/kg, including T1-weighted dynamic and delayed MR images 20 to 40 minutes postinjection. Triphasic contrast-enhanced CT, the comparator examination, was performed within 4 weeks of MR imaging. Standard of references (SOR) were resection histopathology and intraoperative ultrasonography, or combined CT during arterial portography and CT hepatic arteriography; in cases where, although the major lesions were treated, some lesion(s) were not treated, follow-up superparamagnetic iron oxide-enhanced MR imaging was additionally performed. All images were assessed for differences in lesion detection and characterization (specific lesion type) by on-site readers and 3, blinded (off-site) reviewers. All adverse events (AEs) occurring within 72 hours after Gd-EOB-DTPA administration were reported. Results: Overall, 9.6% of patients who received Gd-EOB-DTPA reported 21 drug-related AEs. A total of 151 patients were included in the efficacy analysis. Combined MR imaging showed statistically higher sensitivity in lesion detection (67.5%-79.5%) than unenhanced MR imaging (46.5%-59.1%; P < 0.05 for all). Combined MR imaging also showed higher sensitivity in lesion detection than CT (61.1%-73.0%), with the results being statistically significant (P < 0.05) for on-site readers and 2 of 3 blinded readers. Higher sensitivity in lesion detection with combined MR imaging compared with CT was also clearly demonstrated in the following subgroups: lesions with a diameter ≤20 mm (lesions ≤10 mm: 38.0%-55.4% vs. 26.1%-47.3%, respectively; lesions 10-20 mm: 71.1%-87.3% vs. 65.7%-78.4%, respectively); in cirrhotic patients (64.5%-75.4% vs. 54.5%-70.3%, respectively); and in patients with hepatocellular carcinoma (66.6%-78.6% vs. 59.1%-71.6%, respectively). Combined MR imaging demonstrated a higher proportion of correctly characterized lesions (50.5%-72.1%) than unenhanced MR imaging (30.2%-50.0%; P < 0.05 for all), whereas there were no significant differences compared with CT (49.0%-68.1%), except for one blinded reader (P < 0.05). Conclusion: In this study, hepatocyte-specific Gd-EOB-DTPA was shown to be safe and to improve the detection and characterization of focal hepatic lesions compared with unenhanced MR imaging. When compared with spiral CT, Gd-EOB-DTPA enhanced MRI seems to be beneficial especially for the detection for smaller lesions or hepatocellular carcinoma underlying cirrhotic liver.

Original languageEnglish
Pages (from-to)133-141
Number of pages9
JournalInvestigative Radiology
Volume45
Issue number3
DOIs
Publication statusPublished - 2010 Mar

Fingerprint

Liver Diseases
Hepatocellular Carcinoma
Chronic Disease
Tomography
Magnetic Resonance Imaging
Liver
Spiral Computed Tomography
gadolinium ethoxybenzyl DTPA
Portography
Research Ethics Committees
Tumor Biomarkers
Drug-Related Side Effects and Adverse Reactions
Informed Consent
Hepatocytes
Ultrasonography
Angiography
Magnetic Resonance Spectroscopy
Safety
Injections

Keywords

  • CT
  • Gadoxetic acid
  • Hepatocellular carcinoma
  • Liver
  • MRI
  • Neoplasms

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

Detection and Characterization of Focal Liver Lesions : A Japanese Phase III, Multicenter Comparison between Gadoxetic Acid Disodium-Enhanced Magnetic Resonance Imaging and Contrast-Enhanced Computed Tomography Predominantly in Patients with Hepatocellular Carcinoma and Chronic Liver Disease. / Ichikawa, Tomoaki; Saito, Kazuhiro; Yoshioka, Naoki; Tanimoto, Akihiro; Gokan, Takehiko; Takehara, Yasuo; Kamura, Takeshi; Gabata, Toshifumi; Murakami, Takamichi; Ito, Katsuyoshi; Hirohashi, Shinji; Nishie, Akihiro; Saito, Yoko; Onaya, Hiroaki; Kuwatsuru, Ryohei; Morimoto, Atsuko; Ueda, Koji; Kurauchi, Masayo; Breuer, Josy.

In: Investigative Radiology, Vol. 45, No. 3, 03.2010, p. 133-141.

Research output: Contribution to journalArticle

Ichikawa, T, Saito, K, Yoshioka, N, Tanimoto, A, Gokan, T, Takehara, Y, Kamura, T, Gabata, T, Murakami, T, Ito, K, Hirohashi, S, Nishie, A, Saito, Y, Onaya, H, Kuwatsuru, R, Morimoto, A, Ueda, K, Kurauchi, M & Breuer, J 2010, 'Detection and Characterization of Focal Liver Lesions: A Japanese Phase III, Multicenter Comparison between Gadoxetic Acid Disodium-Enhanced Magnetic Resonance Imaging and Contrast-Enhanced Computed Tomography Predominantly in Patients with Hepatocellular Carcinoma and Chronic Liver Disease', Investigative Radiology, vol. 45, no. 3, pp. 133-141. https://doi.org/10.1097/RLI.0b013e3181caea5b
Ichikawa, Tomoaki ; Saito, Kazuhiro ; Yoshioka, Naoki ; Tanimoto, Akihiro ; Gokan, Takehiko ; Takehara, Yasuo ; Kamura, Takeshi ; Gabata, Toshifumi ; Murakami, Takamichi ; Ito, Katsuyoshi ; Hirohashi, Shinji ; Nishie, Akihiro ; Saito, Yoko ; Onaya, Hiroaki ; Kuwatsuru, Ryohei ; Morimoto, Atsuko ; Ueda, Koji ; Kurauchi, Masayo ; Breuer, Josy. / Detection and Characterization of Focal Liver Lesions : A Japanese Phase III, Multicenter Comparison between Gadoxetic Acid Disodium-Enhanced Magnetic Resonance Imaging and Contrast-Enhanced Computed Tomography Predominantly in Patients with Hepatocellular Carcinoma and Chronic Liver Disease. In: Investigative Radiology. 2010 ; Vol. 45, No. 3. pp. 133-141.
@article{e1a6dc09c39f430ebcc12cb69abed440,
title = "Detection and Characterization of Focal Liver Lesions: A Japanese Phase III, Multicenter Comparison between Gadoxetic Acid Disodium-Enhanced Magnetic Resonance Imaging and Contrast-Enhanced Computed Tomography Predominantly in Patients with Hepatocellular Carcinoma and Chronic Liver Disease",
abstract = "Objectives: To prospectively evaluate the safety and efficacy of combined unenhanced and gadoxetic acid disodium (Gd-EOB-DTPA)-enhanced magnetic resonance (MR) imaging compared with unenhanced MR imaging and triphasic contrast-enhanced spiral computed tomography (CT) for the detection and characterization of focal liver lesions. Materials and Methods: The study was reviewed and approved by the institutional review board at each of the 15 centers involved in the study, and informed written consent was given by all patients. In total, 178 patients with suspected focal hepatic lesions (based, in most patients, on CT, tumor marker and ultrasound examinations) underwent combined MR imaging with a single, rapid injection of Gd-EOB-DTPA 0.025 mmol/kg, including T1-weighted dynamic and delayed MR images 20 to 40 minutes postinjection. Triphasic contrast-enhanced CT, the comparator examination, was performed within 4 weeks of MR imaging. Standard of references (SOR) were resection histopathology and intraoperative ultrasonography, or combined CT during arterial portography and CT hepatic arteriography; in cases where, although the major lesions were treated, some lesion(s) were not treated, follow-up superparamagnetic iron oxide-enhanced MR imaging was additionally performed. All images were assessed for differences in lesion detection and characterization (specific lesion type) by on-site readers and 3, blinded (off-site) reviewers. All adverse events (AEs) occurring within 72 hours after Gd-EOB-DTPA administration were reported. Results: Overall, 9.6{\%} of patients who received Gd-EOB-DTPA reported 21 drug-related AEs. A total of 151 patients were included in the efficacy analysis. Combined MR imaging showed statistically higher sensitivity in lesion detection (67.5{\%}-79.5{\%}) than unenhanced MR imaging (46.5{\%}-59.1{\%}; P < 0.05 for all). Combined MR imaging also showed higher sensitivity in lesion detection than CT (61.1{\%}-73.0{\%}), with the results being statistically significant (P < 0.05) for on-site readers and 2 of 3 blinded readers. Higher sensitivity in lesion detection with combined MR imaging compared with CT was also clearly demonstrated in the following subgroups: lesions with a diameter ≤20 mm (lesions ≤10 mm: 38.0{\%}-55.4{\%} vs. 26.1{\%}-47.3{\%}, respectively; lesions 10-20 mm: 71.1{\%}-87.3{\%} vs. 65.7{\%}-78.4{\%}, respectively); in cirrhotic patients (64.5{\%}-75.4{\%} vs. 54.5{\%}-70.3{\%}, respectively); and in patients with hepatocellular carcinoma (66.6{\%}-78.6{\%} vs. 59.1{\%}-71.6{\%}, respectively). Combined MR imaging demonstrated a higher proportion of correctly characterized lesions (50.5{\%}-72.1{\%}) than unenhanced MR imaging (30.2{\%}-50.0{\%}; P < 0.05 for all), whereas there were no significant differences compared with CT (49.0{\%}-68.1{\%}), except for one blinded reader (P < 0.05). Conclusion: In this study, hepatocyte-specific Gd-EOB-DTPA was shown to be safe and to improve the detection and characterization of focal hepatic lesions compared with unenhanced MR imaging. When compared with spiral CT, Gd-EOB-DTPA enhanced MRI seems to be beneficial especially for the detection for smaller lesions or hepatocellular carcinoma underlying cirrhotic liver.",
keywords = "CT, Gadoxetic acid, Hepatocellular carcinoma, Liver, MRI, Neoplasms",
author = "Tomoaki Ichikawa and Kazuhiro Saito and Naoki Yoshioka and Akihiro Tanimoto and Takehiko Gokan and Yasuo Takehara and Takeshi Kamura and Toshifumi Gabata and Takamichi Murakami and Katsuyoshi Ito and Shinji Hirohashi and Akihiro Nishie and Yoko Saito and Hiroaki Onaya and Ryohei Kuwatsuru and Atsuko Morimoto and Koji Ueda and Masayo Kurauchi and Josy Breuer",
year = "2010",
month = "3",
doi = "10.1097/RLI.0b013e3181caea5b",
language = "English",
volume = "45",
pages = "133--141",
journal = "Investigative Radiology",
issn = "0020-9996",
publisher = "Lippincott Williams and Wilkins",
number = "3",

}

TY - JOUR

T1 - Detection and Characterization of Focal Liver Lesions

T2 - A Japanese Phase III, Multicenter Comparison between Gadoxetic Acid Disodium-Enhanced Magnetic Resonance Imaging and Contrast-Enhanced Computed Tomography Predominantly in Patients with Hepatocellular Carcinoma and Chronic Liver Disease

AU - Ichikawa, Tomoaki

AU - Saito, Kazuhiro

AU - Yoshioka, Naoki

AU - Tanimoto, Akihiro

AU - Gokan, Takehiko

AU - Takehara, Yasuo

AU - Kamura, Takeshi

AU - Gabata, Toshifumi

AU - Murakami, Takamichi

AU - Ito, Katsuyoshi

AU - Hirohashi, Shinji

AU - Nishie, Akihiro

AU - Saito, Yoko

AU - Onaya, Hiroaki

AU - Kuwatsuru, Ryohei

AU - Morimoto, Atsuko

AU - Ueda, Koji

AU - Kurauchi, Masayo

AU - Breuer, Josy

PY - 2010/3

Y1 - 2010/3

N2 - Objectives: To prospectively evaluate the safety and efficacy of combined unenhanced and gadoxetic acid disodium (Gd-EOB-DTPA)-enhanced magnetic resonance (MR) imaging compared with unenhanced MR imaging and triphasic contrast-enhanced spiral computed tomography (CT) for the detection and characterization of focal liver lesions. Materials and Methods: The study was reviewed and approved by the institutional review board at each of the 15 centers involved in the study, and informed written consent was given by all patients. In total, 178 patients with suspected focal hepatic lesions (based, in most patients, on CT, tumor marker and ultrasound examinations) underwent combined MR imaging with a single, rapid injection of Gd-EOB-DTPA 0.025 mmol/kg, including T1-weighted dynamic and delayed MR images 20 to 40 minutes postinjection. Triphasic contrast-enhanced CT, the comparator examination, was performed within 4 weeks of MR imaging. Standard of references (SOR) were resection histopathology and intraoperative ultrasonography, or combined CT during arterial portography and CT hepatic arteriography; in cases where, although the major lesions were treated, some lesion(s) were not treated, follow-up superparamagnetic iron oxide-enhanced MR imaging was additionally performed. All images were assessed for differences in lesion detection and characterization (specific lesion type) by on-site readers and 3, blinded (off-site) reviewers. All adverse events (AEs) occurring within 72 hours after Gd-EOB-DTPA administration were reported. Results: Overall, 9.6% of patients who received Gd-EOB-DTPA reported 21 drug-related AEs. A total of 151 patients were included in the efficacy analysis. Combined MR imaging showed statistically higher sensitivity in lesion detection (67.5%-79.5%) than unenhanced MR imaging (46.5%-59.1%; P < 0.05 for all). Combined MR imaging also showed higher sensitivity in lesion detection than CT (61.1%-73.0%), with the results being statistically significant (P < 0.05) for on-site readers and 2 of 3 blinded readers. Higher sensitivity in lesion detection with combined MR imaging compared with CT was also clearly demonstrated in the following subgroups: lesions with a diameter ≤20 mm (lesions ≤10 mm: 38.0%-55.4% vs. 26.1%-47.3%, respectively; lesions 10-20 mm: 71.1%-87.3% vs. 65.7%-78.4%, respectively); in cirrhotic patients (64.5%-75.4% vs. 54.5%-70.3%, respectively); and in patients with hepatocellular carcinoma (66.6%-78.6% vs. 59.1%-71.6%, respectively). Combined MR imaging demonstrated a higher proportion of correctly characterized lesions (50.5%-72.1%) than unenhanced MR imaging (30.2%-50.0%; P < 0.05 for all), whereas there were no significant differences compared with CT (49.0%-68.1%), except for one blinded reader (P < 0.05). Conclusion: In this study, hepatocyte-specific Gd-EOB-DTPA was shown to be safe and to improve the detection and characterization of focal hepatic lesions compared with unenhanced MR imaging. When compared with spiral CT, Gd-EOB-DTPA enhanced MRI seems to be beneficial especially for the detection for smaller lesions or hepatocellular carcinoma underlying cirrhotic liver.

AB - Objectives: To prospectively evaluate the safety and efficacy of combined unenhanced and gadoxetic acid disodium (Gd-EOB-DTPA)-enhanced magnetic resonance (MR) imaging compared with unenhanced MR imaging and triphasic contrast-enhanced spiral computed tomography (CT) for the detection and characterization of focal liver lesions. Materials and Methods: The study was reviewed and approved by the institutional review board at each of the 15 centers involved in the study, and informed written consent was given by all patients. In total, 178 patients with suspected focal hepatic lesions (based, in most patients, on CT, tumor marker and ultrasound examinations) underwent combined MR imaging with a single, rapid injection of Gd-EOB-DTPA 0.025 mmol/kg, including T1-weighted dynamic and delayed MR images 20 to 40 minutes postinjection. Triphasic contrast-enhanced CT, the comparator examination, was performed within 4 weeks of MR imaging. Standard of references (SOR) were resection histopathology and intraoperative ultrasonography, or combined CT during arterial portography and CT hepatic arteriography; in cases where, although the major lesions were treated, some lesion(s) were not treated, follow-up superparamagnetic iron oxide-enhanced MR imaging was additionally performed. All images were assessed for differences in lesion detection and characterization (specific lesion type) by on-site readers and 3, blinded (off-site) reviewers. All adverse events (AEs) occurring within 72 hours after Gd-EOB-DTPA administration were reported. Results: Overall, 9.6% of patients who received Gd-EOB-DTPA reported 21 drug-related AEs. A total of 151 patients were included in the efficacy analysis. Combined MR imaging showed statistically higher sensitivity in lesion detection (67.5%-79.5%) than unenhanced MR imaging (46.5%-59.1%; P < 0.05 for all). Combined MR imaging also showed higher sensitivity in lesion detection than CT (61.1%-73.0%), with the results being statistically significant (P < 0.05) for on-site readers and 2 of 3 blinded readers. Higher sensitivity in lesion detection with combined MR imaging compared with CT was also clearly demonstrated in the following subgroups: lesions with a diameter ≤20 mm (lesions ≤10 mm: 38.0%-55.4% vs. 26.1%-47.3%, respectively; lesions 10-20 mm: 71.1%-87.3% vs. 65.7%-78.4%, respectively); in cirrhotic patients (64.5%-75.4% vs. 54.5%-70.3%, respectively); and in patients with hepatocellular carcinoma (66.6%-78.6% vs. 59.1%-71.6%, respectively). Combined MR imaging demonstrated a higher proportion of correctly characterized lesions (50.5%-72.1%) than unenhanced MR imaging (30.2%-50.0%; P < 0.05 for all), whereas there were no significant differences compared with CT (49.0%-68.1%), except for one blinded reader (P < 0.05). Conclusion: In this study, hepatocyte-specific Gd-EOB-DTPA was shown to be safe and to improve the detection and characterization of focal hepatic lesions compared with unenhanced MR imaging. When compared with spiral CT, Gd-EOB-DTPA enhanced MRI seems to be beneficial especially for the detection for smaller lesions or hepatocellular carcinoma underlying cirrhotic liver.

KW - CT

KW - Gadoxetic acid

KW - Hepatocellular carcinoma

KW - Liver

KW - MRI

KW - Neoplasms

UR - http://www.scopus.com/inward/record.url?scp=77249111813&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77249111813&partnerID=8YFLogxK

U2 - 10.1097/RLI.0b013e3181caea5b

DO - 10.1097/RLI.0b013e3181caea5b

M3 - Article

C2 - 20098330

AN - SCOPUS:77249111813

VL - 45

SP - 133

EP - 141

JO - Investigative Radiology

JF - Investigative Radiology

SN - 0020-9996

IS - 3

ER -