NCT04455932

HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 476 (estimated)
• Sponsor: Concord Repatriation General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

All international guidelines recommend 6-monthly ultrasound surveillance for patients at risk for liver cancer (hepatocellular carcinoma or HCC), such as patients with cirrhosis. The aim of surveillance is to detect HCC at an early stage when it is still potentially curable. Currently only 4 out of 10 HCCs are detected at the early stage. Ultrasound surveillance for HCC has a wide ranging sensitivity, dependent on many factors such as operator experience, patient body habitus and liver parenchymal heterogeneity due to chronic liver disease and cirrhosis. In a select group of patients, surveillance ultrasound can be suboptimal or near non-diagnostic. Currently no guideline offers an alternative surveillance tool for patients who have suboptimal surveillance ultrasounds.

Detailed description

The investigators plan to conduct a prospective study to examine the diagnostic performance of abbreviated non-contrast MRI (aNC-MRI) versus ultrasound, in a select group of cirrhotic patients with poor ultrasound visualisation.

Conditions

• Hepatocellular Carcinoma
• HCC

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Abbreviated non-contrast MRI of the liver	every 6 months
DIAGNOSTIC_TEST	Ultrasound surveillance	every 6 months
DIAGNOSTIC_TEST	Multiphase contrast-enhanced liver MRI	screening

Timeline

• Start date: 2022-01-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2020-07-02
• Last updated: 2021-09-08

Locations

10 sites across 2 countries: Australia, New Zealand