NCT06312826

Abbreviated MRI Using Gadoxetic Acid Versus Ultrasonography for Surveillance of Early-stage HCC in Patients at High Risk

A Prospective Randomized Comparative Cohort Study to Investigate Abbreviated Magnetic Resonance Imaging Using Gadoxetic Acid and Ultrasonography for Surveillance of Early-stage HCC in Patients at High Risk for HCC

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 806 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Hepatocellular carcinoma (HCC) is the third most frequent cause of cancer-related deaths worldwide. The incidence of HCC has been rapidly rising worldwide over the last two decades. In order to improve survival with curative treatment, regular surveillance to detect early-stage HCC is recommended for at-risk populations. Although ultrasonography (US) has been endorsed as the primary surveillance tool for HCC, a recent meta-analysis found that US has a sensitivity of 47% for detecting early-stage HCC, and its sensitivity for detecting early-stage HCC has been questioned. Many recent studies have explored the potential of alternative surveillance tools for HCC other than US, particularly for high-risk patients. Although complete gadoxetic acid-enhanced magnetic resonance imaging (MRI) demonstrated excellent performance, its high cost and long examination time can hamper its widespread adoption. Abbreviated MRI (AMRI) including hepatobiliary-phase imaging is a promising option to detect potential indicators of HCC, maintaining the benefits of highly sensitive imaging while reducing the examination time by omitting dynamic contrast-enhanced imaging. Because US is the current primary surveillance tool for HCC, this new surveillance tool must be compared with US in a prospective randomized comparative design. Thus, the hypothesis to be proved in this study is as follows: AMRI with gadoxetic acid will show a significantly higher detection rate compared to US for the detection of early-stage HCC in patients with cirrhosis and at high risk of developing HCC, defined as an estimated annual HCC risk of higher than 5%. We will also analyze whether the false-referral rate of AMRI with gadoxetic acid is not compromised by its high detection rate.

Detailed description

A total of 806 subjects will be randomized in a 1:1 ratio into the US group and the AMRI group. Subjects will be evaluated by two rounds of tests with US or AMRI at intervals of 6 months. After the completion of the two evaluation rounds, at least 6 months of clinical follow-up data will be collected to record the occurrence of interval cancer. US group: Subjects will be evaluated by two rounds of tests with abdominal US for the surveillance of HCC at intervals of 6 months. AMRI group: Subjects will be evaluated by two rounds of tests with AMRI with gadoxetic acid for the surveillance of HCC at intervals of 6 months.

Conditions

• Liver Cirrhosis
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Abdominal US	The acquired images included B-mode images of the left hepatic lobe through transverse and longitudinal scans including images of the umbilical portion of the left portal vein, and images of the right hepatic lobe through subcostal and intercostal scans including images of the right hepatic dome, right portal vein, and right hepatic vein with additional images of the confluence of both portal vein and three hepatic veins. When a liver observation was seen, additional images were taken, and its diameter was measured on both transverse and longitudinal planes.
PROCEDURE	AMRI	The study subjects receive intravenous injection of gadoxetic acid (0.025 mmol/kg, Primovist; Bayer, Berlin, Germany) in the waiting room and then proceed to the examination room for MRI testing 15-20 minutes later. The MRI examination is conducted using a 3T MRI machine, and the MRI protocol consists of T2-weighted imaging, diffusion-weighted imaging (b value of 0, 50, and 500 s/mm2), and hepatobiliary phase imaging.

Timeline

• Start date: 2022-08-26
• Primary completion: 2025-11-01
• Completion: 2027-12-01
• First posted: 2024-03-15
• Last updated: 2025-05-31

Locations

1 site across 1 country: South Korea