Abstract
BackgroundUltrasonography (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.MethodsMAGNUS-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.DiscussionMAGNUS-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.Trial registrationThe date of trial registration (NCT02551250) in this study was September 15, 2015, and follow-up is still ongoing.
Highlights
Ultrasonography (US) is recommended as a standard surveillance tool for patients with a high risk of developing hepatocellular carcinoma (HCC)
The purpose of this study is to investigate the feasibility and efficacy of non-contrast magnetic resonance imaging (MRI) compared with US as a surveillance tool for the development of HCC in patients with high-risk factors
Suspicious findings on MRI suggestive of HCC are defined as follows: 1) hepatic lesion with high signal intensity on T2-weighted image (T2WI), 2) fat-containing lesion on T1-weighted image (T1WI), 3) size increase greater than 100% in >6 months, and 4) diffusion restriction on diffusion weighted image (DWI)
Summary
Ultrasonography (US) is recommended as a standard surveillance tool for patients with a high risk of developing hepatocellular carcinoma (HCC). 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. Detection of HCC at an early stage is important, and the need for regular surveillance of high-risk patients is essential. Several studies have demonstrated that HCC surveillance leads to early detection, improved overall survival, and cost-effectiveness [2, 6,7,8]. A better surveillance tool with an improved sensitivity and specificity is clearly needed
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