Hepatocellular CarcinomaNCT04455932
HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
A study testing Abbreviated non-contrast MRI of the liver, Ultrasound surveillance and Multiphase contrast-enhanced liver MRI in people with Hepatocellular Carcinoma and HCC, run by Concord Repatriation General Hospital at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma, HCC
- What is being tested?
- Abbreviated non-contrast MRI of the liver, Ultrasound surveillance and Multiphase contrast-enhanced liver MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jan 2022to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Isaac Lui, MD contact
10 sites in 2 countries
Australia9 sites, 9 recruiting
- Not yet recruiting
Princess Alexandra Hospital
Brisbane, Queensland
Kate McLean
Kate McLean
- Not yet recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Yu Xuan Kitzing
Yu Xuan Kitzing
- Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Jessica Yang
Alice Lee
- Not yet recruiting
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Tom Sutherland
Tom Sutherland
- Not yet recruiting
Gosford Hospital
Gosford, New South Wales
Jonathan Ho
Susanna Won
- Not yet recruiting
Austin Hospital
Heidelberg, Victoria, 3084
Numan Kutaiba
Numan Kutaiba
- Not yet recruiting
Royal Perth Hospital
Perth, Western Australia
James Seow
James Seow
- Not yet recruiting
Prince of Wales Hospital
Randwick, New South Wales, 2031
Dean Rabinowitz
Dean Rabinowitz
- Not yet recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Jacob George
Anthony Peduto
New Zealand1 site, 1 recruiting
- Not yet recruiting
North Shore Hospital
Takapuna, Auckland, 0620
Chris McKee
Chris McKee
About this study
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, HCC
- Being tested
- Abbreviated non-contrast MRI of the liver, Ultrasound surveillance, Multiphase contrast-enhanced liver MRI
- Keywords
- Ultrasound, MRI, HCC, Hepatocellular carcinoma, aMRI, NC-aMRI, Screening, Surveillance
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbreviated non-contrast MRI of the liverDiagnostic test
Also called aNC-MRI
every 6 months
Ultrasound surveillanceDiagnostic test
Also called US surveillance
every 6 months
Multiphase contrast-enhanced liver MRIDiagnostic test
Also called Multiphase liver MRI
screening
| Study group | Role | What they receive |
|---|---|---|
| HCC surveillance with US and aNC-MRI | Experimental | Not described Receives: Diagnostic Test: Abbreviated non-contrast MRI of the liver; Diagnostic Test: Ultrasound surveillance; Diagnostic Test: Multiphase contrast-enhanced liver MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 or 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study startJan 2022 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Concord Repatriation General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jessica Yang, Concord Repatriation General Hospital
- Investigators
- Jessica Yang, MBBS, Principal investigator, Concord Repatriation General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455932
- Sponsor's protocol ID
- 2019/PID15472
- Status last verified
- Sep 2021
- First submitted
- 27 Jun 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Son JH, Choi SH, Kim SY, Jang HY, Byun JH, Won HJ, Lee SJ, Lim YS. Validation of US Liver Imaging Reporting and Data System Version 2017 in Patients at High Risk for Hepatocellular Carcinoma. Radiology. 2019 Aug;292(2):390-397. doi: 10.1148/radiol.2019190035. Epub 2019 Jun 18.
PubMed 31210614Singal AG, Pillai A, Tiro J. Early detection, curative treatment, and survival rates for hepatocellular carcinoma surveillance in patients with cirrhosis: a meta-analysis. PLoS Med. 2014 Apr 1;11(4):e1001624. doi: 10.1371/journal.pmed.1001624. eCollection 2014 Apr.
PubMed 24691105Tzartzeva K, Obi J, Rich NE, Parikh ND, Marrero JA, Yopp A, Waljee AK, Singal AG. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018 May;154(6):1706-1718.e1. doi: 10.1053/j.gastro.2018.01.064. Epub 2018 Feb 6.
PubMed 29425931Hanna RF, Miloushev VZ, Tang A, Finklestone LA, Brejt SZ, Sandhu RS, Santillan CS, Wolfson T, Gamst A, Sirlin CB. Comparative 13-year meta-analysis of the sensitivity and positive predictive value of ultrasound, CT, and MRI for detecting hepatocellular carcinoma. Abdom Radiol (NY). 2016 Jan;41(1):71-90. doi: 10.1007/s00261-015-0592-8.
PubMed 26830614Colli A, Fraquelli M, Casazza G, Massironi S, Colucci A, Conte D, Duca P. Accuracy of ultrasonography, spiral CT, magnetic resonance, and alpha-fetoprotein in diagnosing hepatocellular carcinoma: a systematic review. Am J Gastroenterol. 2006 Mar;101(3):513-23. doi: 10.1111/j.1572-0241.2006.00467.x.
PubMed 16542288Chernyak V, Fowler KJ, Kamaya A, Kielar AZ, Elsayes KM, Bashir MR, Kono Y, Do RK, Mitchell DG, Singal AG, Tang A, Sirlin CB. Liver Imaging Reporting and Data System (LI-RADS) Version 2018: Imaging of Hepatocellular Carcinoma in At-Risk Patients. Radiology. 2018 Dec;289(3):816-830. doi: 10.1148/radiol.2018181494. Epub 2018 Sep 25.
PubMed 30251931European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.
PubMed 29628281D'Avola D, Labgaa I, Villanueva A. Natural history of nonalcoholic steatohepatitis/nonalcoholic fatty liver disease-hepatocellular carcinoma: Magnitude of the problem from a hepatology clinic perspective. Clin Liver Dis (Hoboken). 2016 Oct 27;8(4):100-104. doi: 10.1002/cld.579. eCollection 2016 Oct. No abstract available.
PubMed 31041073Saunders D, Seidel D, Allison M, Lyratzopoulos G. Systematic review: the association between obesity and hepatocellular carcinoma - epidemiological evidence. Aliment Pharmacol Ther. 2010 May;31(10):1051-63. doi: 10.1111/j.1365-2036.2010.04271.x. Epub 2010 Feb 18.
PubMed 20175765Wang C, Wang X, Gong G, Ben Q, Qiu W, Chen Y, Li G, Wang L. Increased risk of hepatocellular carcinoma in patients with diabetes mellitus: a systematic review and meta-analysis of cohort studies. Int J Cancer. 2012 Apr 1;130(7):1639-48. doi: 10.1002/ijc.26165. Epub 2011 Jul 28.
PubMed 21544812Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
PubMed 26707365Chitturi S, Wong VW, Chan WK, Wong GL, Wong SK, Sollano J, Ni YH, Liu CJ, Lin YC, Lesmana LA, Kim SU, Hashimoto E, Hamaguchi M, Goh KL, Fan J, Duseja A, Dan YY, Chawla Y, Farrell G, Chan HL. The Asia-Pacific Working Party on Non-alcoholic Fatty Liver Disease guidelines 2017-Part 2: Management and special groups. J Gastroenterol Hepatol. 2018 Jan;33(1):86-98. doi: 10.1111/jgh.13856. No abstract available.
PubMed 28692197Benson AB 3rd, D'Angelica MI, Abbott DE, Abrams TA, Alberts SR, Saenz DA, Are C, Brown DB, Chang DT, Covey AM, Hawkins W, Iyer R, Jacob R, Karachristos A, Kelley RK, Kim R, Palta M, Park JO, Sahai V, Schefter T, Schmidt C, Sicklick JK, Singh G, Sohal D, Stein S, Tian GG, Vauthey JN, Venook AP, Zhu AX, Hoffmann KG, Darlow S. NCCN Guidelines Insights: Hepatobiliary Cancers, Version 1.2017. J Natl Compr Canc Netw. 2017 May;15(5):563-573. doi: 10.6004/jnccn.2017.0059.
PubMed 28476736Burak KW, Sherman M. Hepatocellular carcinoma: Consensus, controversies and future directions. A report from the Canadian Association for the Study of the Liver Hepatocellular Carcinoma Meeting. Can J Gastroenterol Hepatol. 2015 May;29(4):178-84. doi: 10.1155/2015/824263.
PubMed 25965437Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.
PubMed 28130846
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
- ClinicalTrials.gov ID
- NCT04455932
- Acronym / sponsor ID
- 2019/PID15472
- Conditions
- Hepatocellular Carcinoma, HCC
- Keywords
- Ultrasound, MRI, HCC, Hepatocellular carcinoma, aMRI, NC-aMRI, Screening, Surveillance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- Concord Repatriation General HospitalUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbreviated non-contrast MRI of the liverAlso: aNC-MRIevery 6 months | Diagnostic test | HCC surveillance with US and aNC-MRI |
| Ultrasound surveillanceAlso: US surveillanceevery 6 months | Diagnostic test | HCC surveillance with US and aNC-MRI |
| Multiphase contrast-enhanced liver MRIAlso: Multiphase liver MRIscreening | Diagnostic test | HCC surveillance with US and aNC-MRI |
Primary outcome
HCC detection with US surveillance versus aNC-MRI surveillance
Time frame: 3 or 5 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Results publication: PubMed 31210614Son JH, Choi SH, Kim SY, Jang HY, Byun JH, Won HJ, Lee SJ, Lim YS. Validation of US Liver Imaging Reporting and Data System Version 2017 in Patients at High Risk for Hepatocellular Carcinoma. Radiology. 2019 Aug;292(2):390-397. doi: 10.1148/radiol.2019190035. Epub 2019 Jun 18.
- Results publication: PubMed 24691105Singal AG, Pillai A, Tiro J. Early detection, curative treatment, and survival rates for hepatocellular carcinoma surveillance in patients with cirrhosis: a meta-analysis. PLoS Med. 2014 Apr 1;11(4):e1001624. doi: 10.1371/journal.pmed.1001624. eCollection 2014 Apr.
- Results publication: PubMed 29425931Tzartzeva K, Obi J, Rich NE, Parikh ND, Marrero JA, Yopp A, Waljee AK, Singal AG. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018 May;154(6):1706-1718.e1. doi: 10.1053/j.gastro.2018.01.064. Epub 2018 Feb 6.
- Results publication: PubMed 26830614Hanna RF, Miloushev VZ, Tang A, Finklestone LA, Brejt SZ, Sandhu RS, Santillan CS, Wolfson T, Gamst A, Sirlin CB. Comparative 13-year meta-analysis of the sensitivity and positive predictive value of ultrasound, CT, and MRI for detecting hepatocellular carcinoma. Abdom Radiol (NY). 2016 Jan;41(1):71-90. doi: 10.1007/s00261-015-0592-8.
- Results publication: PubMed 16542288Colli A, Fraquelli M, Casazza G, Massironi S, Colucci A, Conte D, Duca P. Accuracy of ultrasonography, spiral CT, magnetic resonance, and alpha-fetoprotein in diagnosing hepatocellular carcinoma: a systematic review. Am J Gastroenterol. 2006 Mar;101(3):513-23. doi: 10.1111/j.1572-0241.2006.00467.x.
- Results publication: PubMed 30251931Chernyak V, Fowler KJ, Kamaya A, Kielar AZ, Elsayes KM, Bashir MR, Kono Y, Do RK, Mitchell DG, Singal AG, Tang A, Sirlin CB. Liver Imaging Reporting and Data System (LI-RADS) Version 2018: Imaging of Hepatocellular Carcinoma in At-Risk Patients. Radiology. 2018 Dec;289(3):816-830. doi: 10.1148/radiol.2018181494. Epub 2018 Sep 25.
- Results publication: PubMed 29628281European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.
- Results publication: PubMed 31041073D'Avola D, Labgaa I, Villanueva A. Natural history of nonalcoholic steatohepatitis/nonalcoholic fatty liver disease-hepatocellular carcinoma: Magnitude of the problem from a hepatology clinic perspective. Clin Liver Dis (Hoboken). 2016 Oct 27;8(4):100-104. doi: 10.1002/cld.579. eCollection 2016 Oct. No abstract available.
- Results publication: PubMed 20175765Saunders D, Seidel D, Allison M, Lyratzopoulos G. Systematic review: the association between obesity and hepatocellular carcinoma - epidemiological evidence. Aliment Pharmacol Ther. 2010 May;31(10):1051-63. doi: 10.1111/j.1365-2036.2010.04271.x. Epub 2010 Feb 18.
- Results publication: PubMed 21544812Wang C, Wang X, Gong G, Ben Q, Qiu W, Chen Y, Li G, Wang L. Increased risk of hepatocellular carcinoma in patients with diabetes mellitus: a systematic review and meta-analysis of cohort studies. Int J Cancer. 2012 Apr 1;130(7):1639-48. doi: 10.1002/ijc.26165. Epub 2011 Jul 28.
- Results publication: PubMed 26707365Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
- Results publication: PubMed 28692197Chitturi S, Wong VW, Chan WK, Wong GL, Wong SK, Sollano J, Ni YH, Liu CJ, Lin YC, Lesmana LA, Kim SU, Hashimoto E, Hamaguchi M, Goh KL, Fan J, Duseja A, Dan YY, Chawla Y, Farrell G, Chan HL. The Asia-Pacific Working Party on Non-alcoholic Fatty Liver Disease guidelines 2017-Part 2: Management and special groups. J Gastroenterol Hepatol. 2018 Jan;33(1):86-98. doi: 10.1111/jgh.13856. No abstract available.
- US LIRADS CORE 2017Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isaac Lui, MD contact
Jessica Yang, MBBS principal investigator
Concord Repatriation General Hospital
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbreviated non-contrast MRI of the liver, Ultrasound surveillance and Multiphase contrast-enhanced liver MRI in people with Hepatocellular Carcinoma and HCC, run by Concord Repatriation General Hospital at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Yang, MBBS (+61297676495, jessica.yang1@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCC detection with US surveillance versus aNC-MRI surveillance (time frame: 3 or 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04455932, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.