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

RECRUITING

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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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:

1. 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

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

3. 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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Eligibility

Age eligible for study : 20 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-01-01

Primary completion: 2026-12-01

Study completion finish: 2027-03-01

Study type

SCREENING

Phase

Trial ID

NCT04455932

Intervention or treatment

DIAGNOSTIC_TEST: Abbreviated non-contrast MRI of the liver

DIAGNOSTIC_TEST: Ultrasound surveillance

DIAGNOSTIC_TEST: Multiphase contrast-enhanced liver MRI

Conditions

• Hepatocellular Carcinoma
• HCC

Image related to Hepatocellular Carcinoma

Condition: Hepatocellular Carcinoma, HCC
DIAGNOSTIC_TEST: Abbreviated non-contrast MRI of the liver and other drugs
Camperdown, New South Wales, Australia and more
Sponsor: Concord Repatriation General Hospital

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Prince Alfred Hospital

Research sites nearby

Select from list below to view details:

Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: HCC surveillance with US and aNC-MRI Not Specified	DIAGNOSTIC_TEST: Abbreviated non-contrast MRI of the liver every 6 months

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
HCC detection with US surveillance versus aNC-MRI surveillance	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	3 or 5 years

Secondary outcome

Frequently Asked Questions

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References

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