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

STATUS

Recruiting
End date

Mar 5, 2026
participants needed

476
sponsor

Concord Repatriation General Hospital

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Updated on 19 February 2024

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cancer

platelet count

hypertension

carcinoma

cirrhosis

liver disease

encephalopathy

ascites

fibroscan

hepatocellular carcinoma

liver cancer

liver mri

contrast-enhanced magnetic resonance imaging

liver ultrasound

Summary

Show definitions

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

Condition	Adenocarcinoma, Adenocarcinoma, HEPATIC NEOPLASM, liver cancer, HEPATOCELLULAR CARCINOMA, liver cancer
Age	20years - 85years
Treatment	Abbreviated non-contrast MRI of the liver, Ultrasound surveillance, Multiphase contrast-enhanced liver MRI
Clinical Study Identifier	NCT04455932
Sponsor	Concord Repatriation General Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	b'Patients with cirrhosis (all causes of cirrhosis, except obscure causes such as'
	b'vascular or congenital fibrosis) AND reduced visualisation of their liver on'
	b'ultrasound (vB and vC).'
	b'The criteria of cirrhosis can be obtained with any of the following methods:'
	b'Histologically by liver biopsy'
	b'Past signs of decompensated liver disease such as ascites, encephalopathy,'
	b'varices or bacterial peritonitis'
	b'Clinically suspicion of cirrhosis PLUS one of the following:'
	b'Radiological evidence of morphologic changes of the liver and evidence of'
	b'portal hypertension on US, CT or MRI examinations, including the'
	b'identification of hepatic surface nodularity, splenomegaly, portal'
	b'collaterals, varices and ascites'
	b'Fibroscan (transient elastography) median liver stiffness >12.5 kPa, the'
	b'Fibroscan must be performed by an experienced technician and interpreted by'
	b'the hepatologist'
	b'Platelet count <100 (x10^9/L) with no alternative cause'
	b'Absence of previous history or current suspicion of HCC - Absence of HCC is defined by'
	b'liver US, multiphase CT or contrast-enhanced MRI within 6 months prior to surveillance'
	b'Patient is able to comply with scheduled visits, evaluation plans and other study'
	b'procedures in the opinion of the investigator'
	b'Patient is willing to provide written informed consent'
Exclusion Criteria
	b'Contraindications to MRI scan (defibrillator, pacemaker, metallic foreign body, severe'
	b'claustrophobia etc.)'
	b'Contraindications to gadolinium'
	b'Age above 85 years old or younger than 20 years old'
	b'Pregnancy or breast feeding'
	b'Any other condition which, in the opinion of the Investigator, would make the patient'
	b'unsuitable for enrolment for the trial or could interfere with the completion of the'
	b'tudy'

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