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

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma; HCC
• Interventions: Diagnostic Test: Abbreviated non-contrast MRI of the liver; Diagnostic Test: Ultrasound surveillance; Diagnostic Test: Multiphase contrast-enhanced liver MRI

• Registration Number: NCT04455932
• Lead Sponsor: Concord Repatriation General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-06-27
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-08
• Study Start: 2022-01
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCC surveillance with US and aNC-MRI	Abbreviated non-contrast MRI of the liver	-
HCC surveillance with US and aNC-MRI	Ultrasound surveillance	-
HCC surveillance with US and aNC-MRI	Multiphase contrast-enhanced liver MRI	-

Primary Outcome Measures

Name	Time	Method
HCC detection with US surveillance versus aNC-MRI surveillance	3 or 5 years	The detection of hepatic malignancy on the two modalities will be compared; * Sensitivity, specificity, PPV and NPV of HCC detection with US surveillance vs aNC-MRI surveillance; * Correlation with diagnostic imaging (multiphase CT or MRI) and/or histopathology as a reference standard; For the diagnosis of HCC we will accept; * Imaging diagnosis based on the Liver Imaging Reporting and Data System (LI-RADS); * Any pathological proof on biopsy or excision The HCC will then be staged based on the Barcelona clinic liver cancer (BCLC) staging system; For the diagnosis of non-HCC hepatic malignancy we will accept; * Imaging diagnosis based on the Liver Imaging Reporting and Data System (LI-RADS); * Any pathological proof on biopsy or excision

Trial Locations

Locations (10)

Austin Hospital; 🇦🇺 Heidelberg, Victoria, Australia

St Vincent's Hospital Melbourne; 🇦🇺 Fitzroy, Victoria, Australia

Royal Perth Hospital; 🇦🇺 Perth, Western Australia, Australia

Gosford Hospital; 🇦🇺 Gosford, New South Wales, Australia

North Shore Hospital; 🇳🇿 Takapuna, Auckland, New Zealand

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia

Concord Repatriation General Hospital; 🇦🇺 Concord, New South Wales, Australia

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia