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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04455932




Registration number
NCT04455932
Ethics application status
Date submitted
27/06/2020
Date registered
2/07/2020
Date last updated
15/07/2020

Titles & IDs
Public title
HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
Scientific title
HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
Secondary ID [1] 0 0
2019/PID15472
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
HCC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Abbreviated non-contrast MRI of the liver
Diagnosis / Prognosis - Ultrasound surveillance
Diagnosis / Prognosis - Multiphase contrast-enhanced liver MRI

Experimental: HCC surveillance with US and aNC-MRI -


Diagnosis / Prognosis: Abbreviated non-contrast MRI of the liver
every 6 months

Diagnosis / Prognosis: Ultrasound surveillance
every 6 months

Diagnosis / Prognosis: Multiphase contrast-enhanced liver MRI
screening

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
3 or 5 years

Eligibility
Key inclusion 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
Minimum age
20 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Screening
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [7] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [8] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [9] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
- Gosford
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
- Brisbane
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Concord Repatriation General Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04455932
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jessica Yang, MBBS
Address 0 0
Concord Repatriation General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jessica Yang, MBBS
Address 0 0
Country 0 0
Phone 0 0
+61297676495
Fax 0 0
Email 0 0
jessica.yang1@health.nsw.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04455932