TY - JOUR
T1 - Gadoxetic acid-based hepatobiliary MRI in hepatocellular carcinoma
AU - Ricke, Jens
AU - Steffen, Ingo G.
AU - Bargellini, Irene
AU - Berg, Thomas
AU - Bilbao Jaureguizar, José Ignacio
AU - Gebauer, Bernhard
AU - Iezzi, Roberto
AU - Loewe, Christian
AU - Karçaaltincaba, Musturay
AU - Pech, Maciej
AU - Sengel, Christian
AU - van Delden, Otto
AU - Vandecaveye, Vincent
AU - Zech, Christoph J.
AU - Seidensticker, Max
PY - 2020/12/1
Y1 - 2020/12/1
N2 - Background & Aims: SORAMIC is a prospective phase II randomised controlled trial in hepatocellular carcinoma (HCC). It consists of 3 parts: a diagnostic study and 2 therapeutic studies with either curative ablation or palliative Yttrium-90 radioembolisation combined with sorafenib. We report the diagnostic cohort study aimed to determine the accuracy of gadoxetic acid-enhanced magnetic resonance imaging (MRI), including hepatobiliary phase (HBP) imaging features compared with contrast-enhanced computed tomography (CT). The primary objective was the accuracy of treatment decisions stratifying patients for curative or palliative (non-ablation) treatment. Methods: Patients with clinically suspected HCC underwent gadoxetic acid-enhanced MRI (HBP MRI, including dynamic MRI) and contrast-enhanced CT. Blinded read of the image data was performed by 2 reader groups (radiologists, R1 and R2). A truth panel with access to all clinical data and follow-up imaging served as reference. Imaging criteria for curative ablation were defined as up to 4 lesions <5 cm and absence of macrovascular invasion. The primary endpoint was non-inferiority of HBP MRI vs. CT in a first step and superiority in a second step. Results: The intent-to-treat population comprised 538 patients. Treatment decisions matched the truth panel assessment in 83.3% and 81.2% for HBP MRI (R1 and R2), and 73.4% and 70.8% for CT. Non-inferiority and superiority (second step) of HBP MRI vs. CT were demonstrated (odds ratio 1.14 [1.09–1.19]). HBP MRI identified patients with >4 lesions significantly more frequently than CT. Conclusions: In HCC, HBP MRI provided a more accurate decision than CT for a curative vs. palliative treatment strategy. Lay summary: Patients with hepatocellular carcinoma are allocated to curative or palliative treatment according to the stage of their disease. Hepatobiliary imaging using gadoxetic acid-enhanced MRI is more accurate than CT for treatment decision-making.
AB - Background & Aims: SORAMIC is a prospective phase II randomised controlled trial in hepatocellular carcinoma (HCC). It consists of 3 parts: a diagnostic study and 2 therapeutic studies with either curative ablation or palliative Yttrium-90 radioembolisation combined with sorafenib. We report the diagnostic cohort study aimed to determine the accuracy of gadoxetic acid-enhanced magnetic resonance imaging (MRI), including hepatobiliary phase (HBP) imaging features compared with contrast-enhanced computed tomography (CT). The primary objective was the accuracy of treatment decisions stratifying patients for curative or palliative (non-ablation) treatment. Methods: Patients with clinically suspected HCC underwent gadoxetic acid-enhanced MRI (HBP MRI, including dynamic MRI) and contrast-enhanced CT. Blinded read of the image data was performed by 2 reader groups (radiologists, R1 and R2). A truth panel with access to all clinical data and follow-up imaging served as reference. Imaging criteria for curative ablation were defined as up to 4 lesions <5 cm and absence of macrovascular invasion. The primary endpoint was non-inferiority of HBP MRI vs. CT in a first step and superiority in a second step. Results: The intent-to-treat population comprised 538 patients. Treatment decisions matched the truth panel assessment in 83.3% and 81.2% for HBP MRI (R1 and R2), and 73.4% and 70.8% for CT. Non-inferiority and superiority (second step) of HBP MRI vs. CT were demonstrated (odds ratio 1.14 [1.09–1.19]). HBP MRI identified patients with >4 lesions significantly more frequently than CT. Conclusions: In HCC, HBP MRI provided a more accurate decision than CT for a curative vs. palliative treatment strategy. Lay summary: Patients with hepatocellular carcinoma are allocated to curative or palliative treatment according to the stage of their disease. Hepatobiliary imaging using gadoxetic acid-enhanced MRI is more accurate than CT for treatment decision-making.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85106548252&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/33103093
U2 - https://doi.org/10.1016/j.jhepr.2020.100173
DO - https://doi.org/10.1016/j.jhepr.2020.100173
M3 - Article
C2 - 33103093
SN - 2589-5559
VL - 2
JO - JHEP Reports
JF - JHEP Reports
IS - 6
M1 - 100173
ER -