Department of Radiology, Research Institute of Radiological Science, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
BMC Cancer. 2018 Sep 24;18(1):915. doi: 10.1186/s12885-018-4827-2.
Biannual ultrasound (US)-with or without alpha-fetoprotein (AFP)-is recommended by current guidelines for the surveillance of hepatocellular carcinoma (HCC). However, the inadequate sensitivity of US has been a concern. Magnetic resonance imaging (MRI) is known to have high sensitivity in detecting hepatic malignancies, even without contrast enhancement. The purpose of our study is to compare US with noncontrast (unenhanced) MRI for HCC surveillance of high-risk patients.
METHODS/DESIGN: MIRACLE-HCC (usefulness of noncontrast MagnetIc Resonance imAging versus nonContrast ultrasonography for surveiLlancE of HepatoCellular Carcinoma) is a prospective, single-center, nonblinded, balanced-randomized, parallel-group study. This study was approved by our institutional review board, and informed consent will be obtained from all participating patients. All patients with compensated liver cirrhosis will undergo noncontrast US or MRI, with serum AFP testing every 6 months. If a suspicious lesion is newly detected, or if the serum AFP level is elevated in an increasing trend for two consecutive tests, dynamic contrast-enhanced imaging will be performed to confirm the diagnosis. The primary endpoints are detection rates of very early or early stage HCC, stage distribution at the initial diagnosis, and false positive referral rates, which will be compared using Fisher's exact or chi-square tests. The study will include 416 patients in a tertiary academic medical center in South Korea.
MIRACLE-HCC is the first prospective randomized trial to compare the effectiveness of noncontrast MRI and noncontrast US in the surveillance of HCC in at-risk patients. The results of this trial will show whether noncontrast MRI surveillance is superior to noncontrast US surveillance in the early detection of HCC. The trial will also determine whether there are fewer false referrals with noncontrast MRI than with noncontrast US and, eventually, whether there is improvement in the overall survival of HCC patients.
The date of trial registration (ClincalTrials.gov: NCT02514434 ) for this study is July 23, 2015. Enrollment of participants was finished in November 2017. No authors have relationships, conditions, or circumstances that present potential conflicts of interest.
目前的指南建议对肝细胞癌（HCC）进行半年一次的超声（US）检查-联合或不联合甲胎蛋白（AFP）检查。然而，US 的敏感性不足一直是一个问题。磁共振成像（MRI）已被证实具有很高的肝脏恶性肿瘤检测敏感性，即使不进行对比增强。我们研究的目的是比较 US 与非对比（未增强）MRI 用于高危患者的 HCC 监测。
方法/设计：MIRACLE-HCC（非增强磁共振成像与非增强超声检查在肝细胞癌监测中的效用）是一项前瞻性、单中心、非盲、平衡随机、平行组研究。本研究已获得机构审查委员会的批准，并将从所有参与的患者中获得知情同意。所有代偿性肝硬化患者将接受非对比 US 或 MRI 检查，每 6 个月检测一次血清 AFP。如果新发现可疑病变，或者两次连续检测 AFP 水平呈升高趋势，则进行动态对比增强成像以确认诊断。主要终点是非常早期或早期 HCC 的检出率、初始诊断时的分期分布以及假阳性转诊率，将使用 Fisher 精确检验或卡方检验进行比较。该研究将在韩国的一家三级学术医疗中心纳入 416 名患者。
MIRACLE-HCC 是第一项前瞻性随机试验，旨在比较非对比 MRI 和非对比 US 在高危患者 HCC 监测中的效果。该试验的结果将显示非对比 MRI 监测是否优于非对比 US 监测在 HCC 的早期检测。该试验还将确定与非对比 US 相比，非对比 MRI 是否有更少的假转诊，并最终是否可以改善 HCC 患者的总体生存率。
该研究的试验注册日期（ClincalTrials.gov：NCT02514434）为 2015 年 7 月 23 日。参与者的招募于 2017 年 11 月完成。没有作者存在利益关系、情况或可能导致潜在利益冲突的条件。
