■SORAMIC是肝细胞癌(HCC)的一项前瞻性II期随机对照试验。它由3部分组成:一项诊断研究和2项治疗研究,包括治愈性消融或姑息性钇90放射栓塞联合索拉非尼。我们报告了一项诊断队列研究,旨在确定gadoxetic酸增强磁共振成像(MRI)的准确性,包括与对比增强计算机断层扫描(CT)相比的肝胆期(HBP)成像特征。主要目标是治疗决策的准确性,将患者分层以进行治愈性或姑息性(非消融)治疗。
■临床疑似HCC的患者接受了gadoxetic酸增强MRI(HBPMRI,包括动态MRI)和对比增强CT。由2个读取器组(放射科医生,R1和R2)。可以访问所有临床数据和随访成像的事实面板作为参考。治愈性消融的成像标准定义为多达4个<5cm的病变和没有大血管侵犯。主要终点是HBPMRI的非劣效性与第一步是CT,第二步是优势。
■意向治疗人群包括538名患者。HBPMRI(R1和R2)的治疗决策与事实小组评估相符,分别为83.3%和81.2%,CT为73.4%和70.8%。HBPMRI的非劣效性和优越性(第二步)与CT显示(比值比1.14[1.09-1.19])。HBPMRI识别>4个病灶的患者的频率明显高于CT。
■在HCC中,HBPMRI提供了比CT更准确的治疗决策姑息治疗策略。
■肝细胞癌患者根据其疾病阶段进行治愈性或姑息性治疗。使用gadoxetic酸增强的MRI进行肝胆成像比CT更准确地进行治疗决策。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: In HCC, HBP MRI provided a more accurate decision than CT for a curative vs. palliative treatment strategy.
UNASSIGNED: 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.