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NCT Number: NCT04455932

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms HCC Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with cirrhosis (all causes of cirrhosis, except obscure causes such as vascular or congenital fibrosis) AND reduced visualisation of their liver on ultrasound (vB and vC).
  • The criteria of cirrhosis can be obtained with any of the following methods:
  • Histologically by liver biopsy
  • Past signs of decompensated liver disease such as ascites, encephalopathy, varices or bacterial peritonitis
  • Clinically suspicion of cirrhosis PLUS one of the following:
  • Radiological evidence of morphologic changes of the liver and evidence of portal hypertension on US, CT or MRI examinations, including the identification of hepatic surface nodularity, splenomegaly, portal collaterals, varices and ascites
  • Fibroscan (transient elastography) median liver stiffness >12.5 kPa, the Fibroscan must be performed by an experienced technician and interpreted by the hepatologist
  • Platelet count <100 (x10^9/L) with no alternative cause
  • Absence of previous history or current suspicion of HCC - Absence of HCC is defined by liver US, multiphase CT or contrast-enhanced MRI within 6 months prior to surveillance
  • Patient is able to comply with scheduled visits, evaluation plans and other study procedures in the opinion of the investigator
  • Patient is willing to provide written informed consent

Exclusion criteria

  • Contraindications to MRI scan (defibrillator, pacemaker, metallic foreign body, severe claustrophobia etc.)
  • Contraindications to gadolinium
  • Age above 85 years old or younger than 20 years old
  • Pregnancy or breast feeding
  • Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment for the trial or could interfere with the completion of the study

Treatment and study plan

Abbreviated non-contrast MRI of the liver

Diagnostic Test

every 6 months

Other names: aNC-MRI

Ultrasound Surveillance

Diagnostic Test

every 6 months

Other names: US surveillance

Multiphase contrast-enhanced liver MRI

Diagnostic Test

screening

Other names: Multiphase liver MRI

Primary outcomes

  1. HCC detection with US surveillance versus aNC-MRI surveillance

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Isaac Lui, MD

CONTACT

[email protected]

Jessica Yang, MBBS

CONTACT

[email protected]

+61297676495

Sponsors and collaborators

Lead sponsor

Concord Repatriation General Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 2, 2020
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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