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

NCT04455932 | Recruiting

• 1 other identifier: 2019/PID15472
• Study Type: interventional
• Target: 476
• Locations: 2 countries
• Sites: 10

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.

Conditions

Hepatocellular Carcinoma; HCC

Keywords

Ultrasound; MRI; HCC; Hepatocellular carcinoma; aMRI; NC-aMRI; Screening; Surveillance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

HCC surveillance with US and aNC-MRI

EXPERIMENTAL

Diagnostic Test: Abbreviated non-contrast MRI of the liver; Diagnostic Test: Ultrasound surveillance; Diagnostic Test: Multiphase contrast-enhanced liver MRI

Interventions

Abbreviated non-contrast MRI of the liver DIAGNOSTIC_TEST

every 6 months

Also known as: aNC-MRI

HCC surveillance with US and aNC-MRI

Ultrasound surveillance DIAGNOSTIC_TEST

every 6 months

Also known as: US surveillance

HCC surveillance with US and aNC-MRI

Multiphase contrast-enhanced liver MRI DIAGNOSTIC_TEST

screening

Also known as: Multiphase liver MRI

HCC surveillance with US and aNC-MRI

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Concord Repatriation General Hospital: lead

Study Sites (10)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

NOT YET RECRUITING

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

RECRUITING

Gosford Hospital

Gosford, New South Wales, Australia

NOT YET RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

NOT YET RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

NOT YET RECRUITING

Princess Alexandra Hospital

Brisbane, Queensland, Australia

NOT YET RECRUITING

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

NOT YET RECRUITING

Austin Hospital

Heidelberg, Victoria, 3084, Australia

NOT YET RECRUITING

Royal Perth Hospital

Perth, Western Australia, Australia

NOT YET RECRUITING

North Shore Hospital

Takapuna, Auckland, 0620, New Zealand

NOT YET RECRUITING

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Related Links

• US LIRADS CORE 2017

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jessica Yang, MBBS

  Concord Repatriation General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Yang, MBBS

CONTACT

+61297676495; jessica.yang1@health.nsw.gov.au

Isaac Lui, MD

CONTACT

dr.isaac.lui@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: July 2, 2020
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (9); NZ (1)