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

Recruiting now · Not applicable

Conditions studied: Hepatocellular Carcinoma, HCC

In brief

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.

Key facts

Study ID

NCT04455932

Run by

Concord Repatriation General Hospital

People needed

476

Starts

2022-01-01

Expected to finish

2027-03-01

Last updated by the study team

2021-09-08

Who can join

Age: 20 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Concord Repatriation General Hospital — Concord, New South Wales, Australia (enrolling)
• Gosford Hospital — Gosford, New South Wales, Australia
• Prince of Wales Hospital — Randwick, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• Princess Alexandra Hospital — Brisbane, Queensland, Australia
• St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia
• Austin Hospital — Heidelberg, Victoria, Australia
• Royal Perth Hospital — Perth, Western Australia, Australia
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• North Shore Hospital — Takapuna, Auckland, New Zealand

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.