Comparison of biannual ultrasonography and annual non-contrast liver magnetic resonance imaging as surveillance tools for hepatocellular carcinoma in patients with liver cirrhosis (MAGNUS-HCC): a study protocol

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.

Abbreviated‐protocol screening MRI vs. complete‐protocol diagnostic MRI for detection of hepatocellular carcinoma in patients with cirrhosis: An equivalence study using LI‐RADS v2018

“…While further research is needed to ascertain any adverse effect of macrocyclic GBCA, HCC screening remains a high priority for cirrhosis patients, as HCC is the leading cause of death among cirrhosis patients. Meanwhile, trials assessing the potential feasibility of annual noncontrast MRI in comparison with traditional ultrasound screening are currently ongoing …”

Liver Magnetic Resonance Imaging for Hepatocellular Carcinoma Surveillance

“…21 There is an ongoing prospective, multicenter clinical trial evaluating the use of noncontrast AMRI as an HCC surveillance tool in patients with liver cirrhosis in South Korea. 26 The study aims to assess the detection rate of HCC using US at 6-months intervals compared to yearly noncontrast liver MRI over a 3-years follow-up. 26 In this trial, the AMRI protocol uses five sequences: HASTE T2WI, fast-spin-echo T2WI, Dual-GRE, DWI, and T1-weighted images.…”

“…26 The study aims to assess the detection rate of HCC using US at 6-months intervals compared to yearly noncontrast liver MRI over a 3-years follow-up. 26 In this trial, the AMRI protocol uses five sequences: HASTE T2WI, fast-spin-echo T2WI, Dual-GRE, DWI, and T1-weighted images. This trial might provide more solid evidence to support the utility of noncontrast MRI for HCC surveillance.…”

Surveillance and Diagnosis of Hepatocellular Carcinoma

“…Although contrast‐enhanced computed tomography (CT) and magnetic resonance imaging (MRI) can increase sensitivity for early HCC detection compared with ultrasound, their routine use is limited by physical harms (e.g., radiation and contrast exposure) and high costs . Studies evaluating alternative, cheaper MRI‐based surveillance strategies, including abbreviated and noncontrast protocols, are ongoing . However, until safer and more cost‐effective options are available, ultrasound remains the preferred imaging modality for HCC surveillance.…”