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

  • STATUS
    Recruiting
  • End date
    Mar 22, 2026
  • participants needed
    476
  • sponsor
    Concord Repatriation General Hospital
Updated on 22 July 2020
Investigator
Jessica Yang, MBBS
Primary Contact
Concord Repatriation General Hospital (4.4 mi away) Contact
+9 other location
platelet count
liver cancer
cancer
ascites
liver disease
cirrhosis

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.

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.

Details
Treatment Abbreviated non-contrast MRI of the liver, Ultrasound surveillance, Multiphase contrast-enhanced liver MRI
Clinical Study IdentifierNCT04455932
SponsorConcord Repatriation General Hospital
Last Modified on22 July 2020

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Eligibility

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Inclusion Criteria

Is your age between 20 yrs and 85 yrs?
Gender: Male or Female
Do you have any of these conditions: HEPATIC NEOPLASM or Liver Cancer or Adenocarcinoma or Malignant Adenoma or HEPATOCELLULAR CARCINOMA?
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
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