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HCC Surveillance: Comparison ...

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

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2027-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma HCC

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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HCC surveillance with US and aNC-MRI

Group Type EXPERIMENTAL

Abbreviated non-contrast MRI of the liver

Intervention Type DIAGNOSTIC_TEST

every 6 months

Ultrasound surveillance

Intervention Type DIAGNOSTIC_TEST

every 6 months

Multiphase contrast-enhanced liver MRI

Intervention Type DIAGNOSTIC_TEST

screening

Interventions

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Abbreviated non-contrast MRI of the liver

every 6 months

Intervention Type DIAGNOSTIC_TEST

Ultrasound surveillance

every 6 months

Intervention Type DIAGNOSTIC_TEST

Multiphase contrast-enhanced liver MRI

screening

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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aNC-MRI US surveillance Multiphase liver MRI

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Dr Jessica Yang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Yang, MBBS

Role: PRINCIPAL_INVESTIGATOR

Concord Repatriation General Hospital

Locations

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