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

Study Overview
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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.

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.

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

Conditions
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Hepatocellular Carcinoma, HCC

Intervention / Treatment
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* Diagnostic Test: Abbreviated non-contrast MRI of the liver
* Diagnostic Test: Ultrasound surveillance
* Diagnostic Test: Multiphase contrast-enhanced liver MRI


Participation Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCC surveillance with US and aNC-MRI<br> | Diagnostic Test: Abbreviated non-contrast MRI of the liver<br>* every 6 months<br>* Other names: aNC-MRI;Diagnostic Test: Ultrasound surveillance<br>* every 6 months<br>* Other names: US surveillance;Diagnostic Test: Multiphase contrast-enhanced liver MRI<br>* screening<br>* Other names: Multiphase liver MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, MRI, HCC, Hepatocellular carcinoma, aMRI, NC-aMRI, Screening, Surveillance