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

September 6, 2021 updated by: Dr Jessica Yang, Concord Repatriation General Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 poor ultrasound visualisation.

Study Type

Interventional

Enrollment (Anticipated)

476

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Not yet recruiting
        • Royal Prince Alfred Hospital
        • Contact:
          • Yu Xuan Kitzing
        • Principal Investigator:
          • Yu Xuan Kitzing
        • Principal Investigator:
          • Simone Strasser
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Contact:
          • Jessica Yang
        • Sub-Investigator:
          • Emily He
        • Sub-Investigator:
          • Jeff Chang
        • Principal Investigator:
          • Jessica Yang
      • Gosford, New South Wales, Australia
        • Not yet recruiting
        • Gosford Hospital
        • Contact:
          • Jonathan Ho
        • Contact:
          • Susanna Won
        • Principal Investigator:
          • Jonathan Ho
        • Principal Investigator:
          • Susanna Won
        • Principal Investigator:
          • Satbir Singh
      • Randwick, New South Wales, Australia, 2031
        • Not yet recruiting
        • Prince of Wales Hospital
        • Contact:
          • Dean Rabinowitz
        • Principal Investigator:
          • Dean Rabinowitz
        • Principal Investigator:
          • Stephen Riordan
      • Westmead, New South Wales, Australia, 2145
        • Not yet recruiting
        • Westmead Hospital
        • Principal Investigator:
          • Anthony Peduto
        • Principal Investigator:
          • Jacob George
    • Queensland
      • Brisbane, Queensland, Australia
        • Not yet recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Kate McLean
        • Principal Investigator:
          • Kate McLean
        • Principal Investigator:
          • Katherine Stuart
        • Principal Investigator:
          • Caroline Tallis
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Not yet recruiting
        • St Vincent's Hospital Melbourne
        • Contact:
          • Tom Sutherland
        • Principal Investigator:
          • Tom Sutherland
      • Heidelberg, Victoria, Australia, 3084
        • Not yet recruiting
        • Austin Hospital
        • Contact:
          • Numan Kutaiba
        • Principal Investigator:
          • Numan Kutaiba
    • Western Australia
      • Perth, Western Australia, Australia
        • Not yet recruiting
        • Royal Perth Hospital
        • Contact:
          • James Seow
        • Principal Investigator:
          • James Seow
        • Principal Investigator:
          • Wendy Cheng
  • New Zealand
    • Auckland
      • Takapuna, Auckland, New Zealand, 0620
        • Not yet recruiting
        • North Shore Hospital
        • Contact:
          • Chris McKee
        • Principal Investigator:
          • Chris McKee
        • Principal Investigator:
          • Jash Agraval
        • Principal Investigator:
          • John Perry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HCC surveillance with US and aNC-MRI
Diagnostic test: Abbreviated non-contrast MRI of the liver
every 6 months
Other Names:
  • aNC-MRI
Diagnostic test: Ultrasound surveillance
every 6 months
Other Names:
  • US surveillance
Diagnostic test: Multiphase contrast-enhanced liver MRI
screening
Other Names:
  • Multiphase liver MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCC detection with US surveillance versus aNC-MRI surveillance
Time Frame: 3 or 5 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Concord Repatriation General Hospital

Investigators

  • Principal Investigator: Jessica Yang, MBBS, Concord Repatriation General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2026

Study Completion (ANTICIPATED)

March 1, 2027

Study Registration Dates

First Submitted

June 27, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (ACTUAL)

July 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 8, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/PID15472

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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