Lyshchik Andrej, Kuon Yeng Escalante Cristina, Siu Xiao Tania, Piscaglia Fabio, Kono Yuko, Medellin-Kowalewski Alexandra, Rodgers Shuchi K, Planz Virginia, Kamaya Aya, Fetzer David T, Berzigotti Annalisa, Radu Iuliana-Pompilia, Sidhu Paul S, Wessner Corinne E, Bradigan Kristen, Eisenbrey John R, Forsberg Flemming, Wilson Stephanie R
From the Department of Radiology, Thomas Jefferson University Hospital, 132 S 10th St, 763G Main Bldg, Philadelphia, PA 19107 (A.L., C.K.Y.E., T.S.X., S.K.R., C.E.W., K.B., J.R.E., F.F.); Division of Internal Medicine, Hepatobiliary and Immunoallergic Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (F.P.); Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy (F.P.); University of California San Diego, San Diego, Calif (Y.K.); University of Calgary, Calgary, Canada (A.M.K., S.R.W.); Einstein Medical Center, Philadelphia, Pa (S.K.R.); Vanderbilt University, Nashville, Tenn (V.P.); Stanford University, Stanford, Calif (A.K.); UT Southwestern Medical Center, Dallas, Tex (D.T.F.); Department of Visceral Surgery and Medicine, Bern University Hospital, University of Bern, Bern, Switzerland (A.B., I.P.R.); Department of Imaging Sciences, School of Biomedical Engineering and Imaging Sciences, Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom (P.S.S.); and Department of Radiology, King's College Hospital, London, United Kingdom (P.S.S.).
Radiology. 2025 Jan;314(1):e240916. doi: 10.1148/radiol.240916.
Background Indeterminate focal liver observations in patients at risk for hepatocellular carcinoma (HCC) may require invasive biopsy or follow-up, which could lead to delays in definitive categorization and to postponement of treatment. Purpose To examine clinical effect of contrast-enhanced US (CEUS) in participants with high-risk indeterminate liver observations categorized as Liver Imaging Reporting and Data System (LI-RADS) category LR-4 (probably HCC) or LI-RADS category LR-M (probably or definitely malignant but not HCC specific) at CT or MRI. Materials and Methods This was a secondary analysis of a prospective international multicenter validation study for CEUS LI-RADS (January 2018 to August 2021). CEUS was performed within 4 weeks of CT or MRI. Tissue histologic and CT or MRI follow-up data were used as reference standards. Clinical effect of CEUS for HCC was evaluated in observations 10 mm or larger categorized as CT/MRI LR-4 and LR-M. Results Included were 109 participants (mean age, 64.3 years ± 8.3 [SD]; 68.8% [75 of 109] male participants) with 113 observations (≥10 mm) categorized as CT/MRI LR-4 (53.1%; 60 of 113) or LR-M (46.9%; 53 of 113). CEUS resulted in management recommendation changes in 33.6% (95% CI: 25, 43; 38 of 113) of observations; among these, 95% (95% CI: 82, 99; 36 of 38) were correct. A total of 30.1% (34 of 113) of CT/MRI LR-4 and LR-M observations were categorized at CEUS as LI-RADS category LR-5 (definite HCC), making biopsy unnecessary; 94% (32 of 34) of these categorizations were correct. Of CT/MRI LR-4 observations, 7% (four of 60) were categorized as CEUS LR-M; subsequent biopsy confirmed non-HCC malignancy in all participants. Clinical impact of CEUS was more substantial for observations 20 mm or larger ( = 68); CEUS helped appropriately categorize both LR-5 and LR-M lesions as HCC and non-HCC malignancies, respectively, and resulted in management recommendation changes in 40% (27 of 68) of observations with 100% accuracy. Conclusion CEUS resolved some high-risk indeterminate liver observations (categorized as LR-4 and LR-M at CT or MRI), with particularly high clinical impact for observations measuring at least 20 mm. Clinical trial registration no. NCT03318380 © RSNA, 2025
肝细胞癌（HCC）高危患者的肝脏局灶性病变性质不明，可能需要进行侵入性活检或随访，这可能导致明确分类延迟和治疗推迟。目的：探讨超声造影（CEUS）对CT或MRI检查中分类为肝脏影像报告和数据系统（LI-RADS）LR-4类（可能为HCC）或LI-RADS LR-M类（可能或肯定为恶性但非HCC特异性）的高危肝脏性质不明病变患者的临床效果。材料与方法：这是一项对CEUS LI-RADS前瞻性国际多中心验证研究（2018年1月至2021年8月）的二次分析。CEUS在CT或MRI检查后4周内进行。组织学和CT或MRI随访数据用作参考标准。对分类为CT/MRI LR-4和LR-M且直径≥10 mm的病变，评估CEUS对HCC的临床效果。结果：纳入109例参与者（平均年龄64.3岁±8.3[标准差]；68.8%[109例中的75例]为男性），有113个病变（≥10 mm）分类为CT/MRI LR-4（53.1%；113例中的60例）或LR-M（46.9%；113例中的53例）。CEUS使33.6%（95%CI：25，43；113例中的38例）的病变管理建议发生改变；其中95%（95%CI：82，99；38例中的36例）正确。共有30.1%（113例中的34例）的CT/MRI LR-4和LR-M病变在CEUS上分类为LI-RADS LR-5类（肯定为HCC），无需活检；这些分类中94%（34例中的32例）正确。在CT/MRI LR-4病变中，7%（60例中的4例）在CEUS上分类为LR-M；后续活检证实所有参与者均为非HCC恶性病变。CEUS对直径≥20 mm的病变（n = 68）临床影响更大；CEUS有助于将LR-5和LR-M病变分别正确分类为HCC和非HCC恶性病变，并使40%（68例中的27例）的病变管理建议发生改变，准确率达100%。结论：CEUS解决了一些高危肝脏性质不明病变（CT或MRI分类为LR-4和LR-M），对至少20 mm的病变临床影响尤为显著。临床试验注册号：NCT03318380 © RSNA，2025
