Status:
RECRUITING
HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
Lead Sponsor:
Concord Repatriation General Hospital
Conditions:
Hepatocellular Carcinoma
HCC
Eligibility:
All Genders
20-85 years
Phase:
NA
Brief Summary
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 surveillan...
Detailed 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 po...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
476 Patients enrolled
Trial Details
Trial ID
NCT04455932
Start Date
January 1 2022
End Date
March 1 2027
Last Update
September 8 2021
Active Locations (10)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
3
Gosford Hospital
Gosford, New South Wales, Australia
4
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031