From the Department of Radiology (E.S., C.M.S., F.F., C.E.W., A.L., P.O., J.B.L., R.B., C.G.R., H.N., A.T., K.A., K.B., J.R.E.), Sidney Kimmel Medical College (E.S.), Division of Biostatistics, Department of Pharmacology, Physiology, and Cancer Biology (S.W.K.), and Department of Medicine (J.C.), Thomas Jefferson University, 132 S 10th St, 796 E Main Building, Philadelphia, PA 19107; Department of Radiology, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pa (S.S., S.S.N., S.H., M.C.S.); Department of Radiology, University of Texas Southwestern Medical Center, Dallas, Tex (R.F.M.); Cancer Prevention and Research Institute of Texas, Austin, Tex (R.F.M.); and Departments of Medicine and Radiology, University of California, San Diego, La Jolla, Calif (Y.K.).
Radiology. 2023 Oct;309(1):e230727. doi: 10.1148/radiol.230727.
Background Contrast-enhanced (CE) US has been studied for use in the detection of residual viable hepatocellular carcinoma (HCC) after locoregional therapy, but multicenter data are lacking. Purpose To compare two-dimensional (2D) and three-dimensional (3D) CE US diagnostic performance with that of CE MRI or CT, the current clinical standard, in the detection of residual viable HCC after transarterial chemoembolization (TACE) in a prospective multicenter trial. Materials and Methods Participants aged at least 21 years with US-visible HCC scheduled for TACE were consecutively enrolled at one of three participating academic medical centers from May 2016 to March 2022. Each underwent baseline 2D and 3D CE US before TACE, 2D and 3D CE US 1-2 weeks and/or 4-6 weeks after TACE, and CE MRI or CT 4-6 weeks after TACE. CE US and CE MRI or CT were evaluated by three fellowship-trained radiologists for the presence or absence of viable tumors and were compared with reference standards of pathology (18%), angiography on re-treatment after identification of residual disease at 1-2-month follow-up imaging (31%), 4-8-month CE MRI or CT (42%), or short-term (approximately 1-2 months) CE MRI or CT if clinically decompensated and estimated viability was greater than 50% at imaging (9%). Diagnostic performance criteria, including sensitivity and specificity, were obtained for each modality and time point with generalized estimating equation analysis. Results A total of 132 participants were included (mean age, 64 years ± 7 [SD], 87 male). Sensitivity of 2D CE US 4-6 weeks after TACE was 91% (95% CI: 84, 95), which was higher than that of CE MRI or CT (68%; 95% CI: 58, 76; < .001). Sensitivity of 3D CE US 4-6 weeks after TACE was 89% (95% CI: 81, 94), which was higher than that of CE MRI or CT ( < .001), with no evidence of a difference from 2D CE US ( = .22). CE MRI or CT had 85% (95% CI: 76, 91) specificity, higher than that of 4-6-week 2D and 3D CE US (70% [95% CI: 56, 80] and 67% [95% CI: 53, 78], respectively; = .046 and = .023, respectively). No evidence of differences in any diagnostic criteria were observed between 1-2-week and 4-6-week 2D CE US ( > .21). Conclusion The 2D and 3D CE US examinations 4-6 weeks after TACE revealed higher sensitivity in the detection of residual HCC than CE MRI or CT, albeit with lower specificity. Importantly, CE US performance was independent of follow-up time. Clinical trial registration no. NCT02764801 © RSNA, 2023
背景 对比增强（CE）超声已被研究用于检测局部治疗后残留的有活力的肝细胞癌（HCC），但缺乏多中心数据。目的 比较二维（2D）和三维（3D）CE 超声与目前的临床标准 CE MRI 或 CT 在经动脉化疗栓塞（TACE）后检测残留有活力 HCC 的诊断性能，这是一项前瞻性多中心试验。材料与方法 2016 年 5 月至 2022 年 3 月，在三个参与的学术医疗中心中，连续招募至少 21 岁、有超声可见 HCC 并计划接受 TACE 的患者。每位患者在 TACE 前均进行基线 2D 和 3D CE US 检查，在 TACE 后 1-2 周和/或 4-6 周进行 2D 和 3D CE US 检查，在 TACE 后 4-6 周进行 CE MRI 或 CT 检查。三位接受过 fellowship培训的放射科医生对有活力肿瘤的存在或不存在进行了 CE US 和 CE MRI 或 CT 评估，并与病理（18%）、在 1-2 个月随访影像学检查中发现残留疾病后再次治疗的血管造影（31%）、4-8 个月 CE MRI 或 CT（42%）或短期（约 1-2 个月）CE MRI 或 CT（如果临床失代偿且影像学估计活力大于 50%）的参考标准进行了比较。使用广义估计方程分析获得了每种模式和时间点的诊断性能标准，包括敏感性和特异性。结果 共纳入 132 名参与者（平均年龄 64 岁±7[标准差]，87 名男性）。TACE 后 4-6 周 2D CE US 的敏感性为 91%（95%CI：84，95），高于 CE MRI 或 CT（68%；95%CI：58，76；<.001）。TACE 后 4-6 周 3D CE US 的敏感性为 89%（95%CI：81，94），高于 CE MRI 或 CT（<.001），与 2D CE US 无差异（ =.22）。CE MRI 或 CT 的特异性为 85%（95%CI：76，91），高于 4-6 周 2D 和 3D CE US（分别为 70%[95%CI：56，80]和 67%[95%CI：53，78]； =.046 和 =.023）。在 1-2 周和 4-6 周 2D CE US 之间，没有证据表明任何诊断标准存在差异（>.21）。结论 TACE 后 4-6 周的 2D 和 3D CE US 检查在检测残留 HCC 方面的敏感性高于 CE MRI 或 CT，但特异性较低。重要的是，CE US 的性能与随访时间无关。临床试验注册号 NCT02764801 © RSNA，2023
