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Search / Trial NCT04455932

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

Launched by CONCORD REPATRIATION GENERAL HOSPITAL · Jul 1, 2020

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Ultrasound Mri Hcc Hepatocellular Carcinoma A Mri Nc A Mri Screening Surveillance

ClinConnect Summary

This clinical trial is studying the best way to monitor patients at risk for liver cancer, specifically those with cirrhosis who have had difficulty getting clear images from ultrasound tests. Currently, ultrasounds are recommended every six months to catch liver cancer early, but they don't always work well for everyone. This trial compares a different type of imaging, abbreviated non-contrast MRI, to see if it can provide better results for those who struggle with ultrasound visualization.

To participate in this trial, patients must have cirrhosis from any cause (except rare types), and they need to have experienced poor ultrasound results. They should not have been diagnosed with liver cancer in the past six months and must be able to attend scheduled visits. Participants can expect to undergo both MRI scans and ultrasound tests during the study. It's important to note that certain conditions, like having a pacemaker or being pregnant, may prevent someone from joining. This trial aims to find better methods for monitoring liver health in patients who need it most.

Gender

ALL

Eligibility 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

About Concord Repatriation General Hospital

Concord Repatriation General Hospital is a leading healthcare institution dedicated to providing exceptional medical services and advancing clinical research. As a prominent sponsor of clinical trials, the hospital is committed to improving patient outcomes through innovative studies that explore new therapies and treatment protocols. With a focus on veteran care and community health, Concord Repatriation General Hospital leverages its multidisciplinary expertise and state-of-the-art facilities to foster collaboration among healthcare professionals, researchers, and patients. This ensures the highest standards of ethical conduct and scientific rigor in all clinical trials, ultimately contributing to the advancement of medical knowledge and improved healthcare practices.

Locations

Westmead, New South Wales, Australia

Heidelberg, Victoria, Australia

Concord, New South Wales, Australia

Gosford, New South Wales, Australia

Randwick, New South Wales, Australia

Camperdown, New South Wales, Australia

Perth, Western Australia, Australia

Fitzroy, Victoria, Australia

Brisbane, Queensland, Australia

Takapuna, Auckland, New Zealand

Patients applied

0 patients applied

Trial Officials

Jessica Yang, MBBS

Principal Investigator

Concord Repatriation General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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