Department of Radiology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, 93 Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do, 16247, Republic of Korea.
Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul, Republic of Korea.
BMC Cancer. 2017 Dec 21;17(1):877. doi: 10.1186/s12885-017-3819-y.
Ultrasonography (US) is recommended as a standard surveillance tool for patients with a high risk of developing hepatocellular carcinoma (HCC). However, the low sensitivity of US for small HCC can lead to surveillance failure, resulting in advanced stage tumor presentations. For the early detection of HCC in high-risk patients and to improve survival and prognosis, a new efficient imaging tool with a high sensitivity for HCC detection is needed. The purpose of this study is to evaluate and compare the feasibility and efficacy of non-contrast magnetic resonance imaging (MRI) with US as a surveillance tool for HCC in patients with liver cirrhosis.
MAGNUS-HCC is a prospective, multicenter clinical trial with a crossover design for a single arm of patients. This study was approved by six Institutional Review Boards, and informed consent was obtained from all participants. All patients will undergo liver US every 6 months and non-contrast liver MRI every 12 months during a follow-up period of 3 years. If a focal liver lesion suspected of harboring HCC is detected, dynamic liver computed tomography (CT) will be performed to confirm the diagnosis. After the last surveillance round, patients without suspicion of HCC or who are not diagnosed with HCC will be evaluated with a dynamic liver CT to exclude false-negative findings. The primary endpoint is to compare the rate of detection of HCC by US examinations performed at 6-month intervals with that of yearly non-contrast liver MRI studies during a 3-year follow-up. The secondary endpoint is the survival of the patients who developed HCC within the 3-year follow-up period.
MAGNUS-HCC is the first study to compare the feasibility of non-contrast MRI with US as a surveillance tool for the detection of HCC in high-risk patients. We anticipate that the evidence presented in this study will establish the efficacy of non-contrast MRI as a surveillance tool for HCC in high-risk patients.
The date of trial registration ( NCT02551250 ) in this study was September 15, 2015, and follow-up is still ongoing.
超声（US）被推荐作为发生肝细胞癌（HCC）风险较高的患者的标准监测工具。然而，US 对小 HCC 的低敏感性可导致监测失败，导致肿瘤处于晚期。为了在高危患者中早期发现 HCC 并改善生存和预后，需要一种新的、对 HCC 检测具有高灵敏度的高效成像工具。本研究旨在评估和比较 US 和非对比磁共振成像（MRI）作为肝硬化患者 HCC 监测工具的可行性和有效性。
MAGNUS-HCC 是一项前瞻性、多中心、单臂交叉设计的临床试验。该研究获得了六个机构审查委员会的批准，并获得了所有参与者的知情同意。所有患者将在 3 年的随访期间，每 6 个月进行一次肝脏 US 检查，每 12 个月进行一次非对比肝脏 MRI 检查。如果发现疑似 HCC 的局灶性肝病变，将进行动态肝脏计算机断层扫描（CT）以确认诊断。在最后一轮监测后，未怀疑 HCC 或未诊断为 HCC 的患者将接受动态肝脏 CT 评估，以排除假阴性结果。主要终点是比较 3 年随访期间每 6 个月进行的 US 检查与每年进行的非对比肝脏 MRI 研究检测 HCC 的检出率。次要终点是在 3 年随访期间发生 HCC 的患者的生存率。
MAGNUS-HCC 是第一项比较非对比 MRI 与 US 作为高危患者 HCC 检测监测工具的可行性的研究。我们预计，本研究提供的证据将确立非对比 MRI 作为高危患者 HCC 监测工具的有效性。
本研究的试验注册日期（NCT02551250）为 2015 年 9 月 15 日，随访仍在进行中。
