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NCT04455932Recruiting

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

Source: ClinicalTrials.gov · Last updated 8 Sept 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
476 (estimated)
First submitted
27 Jun 2020
Start date
Jan 2022
Primary completion date
Dec 2026
Lead sponsor
Concord Repatriation General Hospital
NCT number
NCT04455932

What you commit to

  • Study type: Interventional
  • Planned participants: 476
  • From Jan 2022 to the primary completion date, Dec 2026
  • 10 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Age

  • Age above 85 years old or younger than 20 years old

Other

  • Contraindications to MRI scan (defibrillator, pacemaker, metallic foreign body, severe claustrophobia etc.)
  • Contraindications to gadolinium
  • Pregnancy or breast feeding

Who the study is looking for

  • 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

Age in the registry: 20 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Princess Alexandra Hospital
Coordinator of this site? Confirm its status
BrisbaneAustraliaNot yet recruiting
Royal Prince Alfred Hospital
Coordinator of this site? Confirm its status
CamperdownAustraliaNot yet recruiting
Concord Repatriation General Hospital
Coordinator of this site? Confirm its status
ConcordAustraliaRecruiting
St Vincent's Hospital Melbourne
Coordinator of this site? Confirm its status
FitzroyAustraliaNot yet recruiting
Gosford Hospital
Coordinator of this site? Confirm its status
GosfordAustraliaNot yet recruiting
Austin Hospital
Coordinator of this site? Confirm its status
HeidelbergAustraliaNot yet recruiting
Royal Perth Hospital
Coordinator of this site? Confirm its status
PerthAustraliaNot yet recruiting
Prince of Wales Hospital
Coordinator of this site? Confirm its status
RandwickAustraliaNot yet recruiting
Westmead Hospital
Coordinator of this site? Confirm its status
WestmeadAustraliaNot yet recruiting
North Shore Hospital
Coordinator of this site? Confirm its status
TakapunaNew ZealandNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.