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

Last updated: September 6, 2021
Sponsor: Concord Repatriation General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Cancer/tumors

Abdominal Cancer

Treatment

N/A

Clinical Study ID

NCT04455932
2019/PID15472
  • Ages 20-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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:

  1. Histologically by liver biopsy

  2. Past signs of decompensated liver disease such as ascites, encephalopathy, varices or bacterial peritonitis

  3. Clinically suspicion of cirrhosis PLUS one of the following:

  4. 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

  5. Fibroscan (transient elastography) median liver stiffness >12.5 kPa, the Fibroscan must be performed by an experienced technician and interpreted by the hepatologist

  6. 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

Study Design

Total Participants: 476
Study Start date:
January 01, 2022
Estimated Completion Date:
March 31, 2027

Study 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.

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Active - Recruiting

  • Gosford Hospital

    Gosford, New South Wales
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Brisbane, Queensland
    Australia

    Site Not Available

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Austin Hospital

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia
    Australia

    Site Not Available

  • North Shore Hospital

    Takapuna, Auckland 0620
    New Zealand

    Site Not Available

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