NCT04455932 HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
| NCT ID | NCT04455932 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Concord Repatriation General Hospital |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 476 participants |
| Start Date | 2022-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 476 participants in total. It began in 2022-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Jessica Yang, MBBS
PRINCIPAL INVESTIGATOR
Concord Repatriation General Hospital
Frequently Asked Questions
Who can join the NCT04455932 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 85 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04455932 currently recruiting?
Yes, NCT04455932 is actively recruiting participants. Contact the research team at jessica.yang1@health.nsw.gov.au for enrollment information.
Where is the NCT04455932 trial being conducted?
This trial is being conducted at Camperdown, Australia, Concord, Australia, Gosford, Australia, Randwick, Australia and 6 additional locations.
Who is sponsoring the NCT04455932 clinical trial?
NCT04455932 is sponsored by Concord Repatriation General Hospital. The principal investigator is Jessica Yang, MBBS at Concord Repatriation General Hospital. The trial plans to enroll 476 participants.
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