Back to resultsHCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
Primary Purpose
Hepatocellular Carcinoma, HCC
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Abbreviated non-contrast MRI of the liver
Ultrasound surveillance
Multiphase contrast-enhanced liver MRI
Sponsored by
About this trial
This is an interventional screening trial for Hepatocellular Carcinoma focused on measuring Ultrasound, MRI, HCC, Hepatocellular carcinoma, aMRI, NC-aMRI, Screening, Surveillance
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:
- 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
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
Sites / Locations
- Royal Prince Alfred Hospital
- Concord Repatriation General HospitalRecruiting
- Gosford Hospital
- Prince of Wales Hospital
- Westmead Hospital
- Princess Alexandra Hospital
- St Vincent's Hospital Melbourne
- Austin Hospital
- Royal Perth Hospital
- North Shore Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HCC surveillance with US and aNC-MRI
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04455932
First Posted
June 27, 2020
Last Updated
September 6, 2021
Sponsor
Concord Repatriation General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04455932
Brief Title
HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
Official Title
HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Concord Repatriation General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, HCC
Keywords
Ultrasound, MRI, HCC, Hepatocellular carcinoma, aMRI, NC-aMRI, Screening, Surveillance
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
476 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HCC surveillance with US and aNC-MRI
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Abbreviated non-contrast MRI of the liver
Other Intervention Name(s)
aNC-MRI
Intervention Description
every 6 months
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound surveillance
Other Intervention Name(s)
US surveillance
Intervention Description
every 6 months
Intervention Type
Diagnostic Test
Intervention Name(s)
Multiphase contrast-enhanced liver MRI
Other Intervention Name(s)
Multiphase liver MRI
Intervention Description
screening
Primary Outcome Measure Information:
Title
HCC detection with US surveillance versus aNC-MRI surveillance
Description
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
Time Frame
3 or 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Yang, MBBS
Phone
+61297676495
Email
jessica.yang1@health.nsw.gov.au
First Name & Middle Initial & Last Name or Official Title & Degree
Isaac Lui, MD
Email
dr.isaac.lui@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Yang, MBBS
Organizational Affiliation
Concord Repatriation General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Xuan Kitzing
First Name & Middle Initial & Last Name & Degree
Yu Xuan Kitzing
First Name & Middle Initial & Last Name & Degree
Simone Strasser
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Yang
First Name & Middle Initial & Last Name & Degree
Alice Lee
First Name & Middle Initial & Last Name & Degree
Emily He
First Name & Middle Initial & Last Name & Degree
Jeff Chang
First Name & Middle Initial & Last Name & Degree
Jessica Yang
Facility Name
Gosford Hospital
City
Gosford
State/Province
New South Wales
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Ho
First Name & Middle Initial & Last Name & Degree
Susanna Won
First Name & Middle Initial & Last Name & Degree
Jonathan Ho
First Name & Middle Initial & Last Name & Degree
Susanna Won
First Name & Middle Initial & Last Name & Degree
Satbir Singh
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dean Rabinowitz
First Name & Middle Initial & Last Name & Degree
Dean Rabinowitz
First Name & Middle Initial & Last Name & Degree
Stephen Riordan
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob George
First Name & Middle Initial & Last Name & Degree
Anthony Peduto
First Name & Middle Initial & Last Name & Degree
Jacob George
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate McLean
First Name & Middle Initial & Last Name & Degree
Kate McLean
First Name & Middle Initial & Last Name & Degree
Katherine Stuart
First Name & Middle Initial & Last Name & Degree
Caroline Tallis
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Sutherland
First Name & Middle Initial & Last Name & Degree
Tom Sutherland
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Numan Kutaiba
First Name & Middle Initial & Last Name & Degree
Numan Kutaiba
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Seow
First Name & Middle Initial & Last Name & Degree
James Seow
First Name & Middle Initial & Last Name & Degree
Wendy Cheng
Facility Name
North Shore Hospital
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
0620
Country
New Zealand
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris McKee
First Name & Middle Initial & Last Name & Degree
Chris McKee
First Name & Middle Initial & Last Name & Degree
Jash Agraval
First Name & Middle Initial & Last Name & Degree
John Perry
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
https://www.acr.org/-/media/ACR/Files/RADS/LI-RADS/CEUS-LI-RADS-2017-Core.pdf?la=en%20n.d
Description
US LIRADS CORE 2017
Learn more about this trial
HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
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