Wu Qiong, Liu Yilun, Sun Di, Wang Yan, Wei Xiaoer, Li Jing, Liu Beibei, Wang Shuhao, Zhou Yan, Hu Haiyan, Zhang Rui, Jiao Qiong, Li Yi, Ying Tao
Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Institute of Ultrasound in Medicine, Shanghai, China.
Institute of Diagnostic and Interventional Radiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.
Front Med (Lausanne). 2022 Aug 9;9:911807. doi: 10.3389/fmed.2022.911807. eCollection 2022.
As the presence of hepatic metastases is very important to cancer patients' clinical stage which would directly affect the selection and application of anti-cancer treatments. Although conventional ultrasound is commonly performed as a screening tool, most of the examinations have relatively poor sensitivity and specificity for detecting liver metastases. Contrast-enhanced ultrasound (CEUS) with Sonazoid has been reported to have the advantage of the diagnosis and therapeutic support of focal hepatic lesions and its specific Kupffer phase whole liver scan (KPWLS) is believed to be sensitive to detect liver metastases. And the purpose of this study is to determine the number, size, location and diagnosis of metastatic lesions, and to compare the results with conventional ultrasound and contrast-enhanced computed tomography (CECT), thus to clarify the application value, indications of Sonazoid-CEUS in screening liver metastasis.
Kupffer phase whole liver scan for metastases (KPWLSM) is a self-control, blind map-reading, single-center, prospective superiority trial. Approved by the institutional review committee, the study period is planned to be from 1 January 2022 to 31 December 2025. Our study will include 330 patients with history of malignant tumors that cling to metastasize to liver. All patients will undergo the examinations of conventional ultrasound, Sonazoid-CEUS, and contrast-enhanced magnetic resonance imaging (CEMRI), and 65 of them should have additional CECT scans. The primary endpoint is the comparative analysis of the numbers of detected liver metastatic lesions among Sonazoid-CEUS, conventional ultrasound and CECT in screening liver metastases. Subjective conditions of patient after injection of Sonazoid will be followed up 3 and 30 days after KPWLSM, and any short-term and long-term adverse events are to be recorded with telephone interviews.
This study has been granted by the Ethics Committee of Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Approval No: 2021-197). When the KPWLSM is completed, we will publish it in an appropriate journal to promote further widespread use.
Trial Registration Number and Date of Registration: Chinese Clinical Trial Registry, ChiCTR2100054385, December 16, 2021.
肝转移的存在对癌症患者的临床分期非常重要，这将直接影响抗癌治疗的选择和应用。尽管传统超声通常作为一种筛查工具，但大多数检查对检测肝转移的敏感性和特异性相对较差。据报道，使用声诺维的超声造影（CEUS）在局灶性肝病变的诊断和治疗支持方面具有优势，其特异性的库普弗细胞期全肝扫描（KPWLS）被认为对检测肝转移敏感。本研究的目的是确定转移瘤的数量、大小、位置和诊断，并将结果与传统超声和增强CT（CECT）进行比较，从而阐明声诺维CEUS在筛查肝转移中的应用价值、适应证。
库普弗细胞期全肝转移瘤扫描（KPWLSM）是一项自身对照、盲法读片、单中心、前瞻性优势试验。经机构审查委员会批准，研究期计划从2022年1月1日至2025年12月31日。我们的研究将纳入330例有肝转移倾向的恶性肿瘤病史患者。所有患者将接受传统超声、声诺维CEUS和增强磁共振成像（CEMRI）检查，其中65例患者应额外进行CECT扫描。主要终点是在筛查肝转移时，对声诺维CEUS、传统超声和CECT检测到的肝转移瘤数量进行比较分析。在KPWLSM后3天和30天对注射声诺维后的患者主观情况进行随访，并通过电话访谈记录任何短期和长期不良事件。
本研究已获得上海交通大学附属第六人民医院伦理委员会批准（批准号：2021-197）。当KPWLSM完成后，我们将在合适的期刊上发表，以促进其进一步广泛应用。
试验注册号和注册日期：中国临床试验注册中心，ChiCTR2100054385，2021年12月16日。
