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

Concord Repatriation General Hospital

Status

Enrolling

Conditions

Hepatocellular Carcinoma

HCC

Treatments

Diagnostic Test: Ultrasound surveillance

Diagnostic Test: Abbreviated non-contrast MRI of the liver

Diagnostic Test: Multiphase contrast-enhanced liver MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT04455932

2019/PID15472

Details and patient eligibility

About

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.

Full 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.

Enrollment

476 estimated patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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