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

STATUS

Recruiting
End date

Mar 5, 2026
participants needed

476
sponsor

Concord Repatriation General Hospital

Send

Updated on 19 February 2024

See if I qualify

cancer

platelet count

hypertension

carcinoma

cirrhosis

liver disease

encephalopathy

ascites

fibroscan

hepatocellular carcinoma

liver cancer

liver mri

contrast-enhanced magnetic resonance imaging

liver ultrasound

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.

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.

Details

Condition	Adenocarcinoma, Adenocarcinoma, HEPATIC NEOPLASM, liver cancer, HEPATOCELLULAR CARCINOMA, liver cancer
Age	20-85 years
Treatment	Abbreviated non-contrast MRI of the liver, Ultrasound surveillance, Multiphase contrast-enhanced liver MRI
Clinical Study Identifier	NCT04455932
Sponsor	Concord Repatriation General Hospital
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	b'Patients with cirrhosis (all causes of cirrhosis, except obscure causes such as'
	b'vascular or congenital fibrosis) AND reduced visualisation of their liver on'
	b'ultrasound (vB and vC).'
	b'The criteria of cirrhosis can be obtained with any of the following methods:'
	b'Histologically by liver biopsy'
	b'Past signs of decompensated liver disease such as ascites, encephalopathy,'
	b'varices or bacterial peritonitis'
	b'Clinically suspicion of cirrhosis PLUS one of the following:'
	b'Radiological evidence of morphologic changes of the liver and evidence of'
	b'portal hypertension on US, CT or MRI examinations, including the'
	b'identification of hepatic surface nodularity, splenomegaly, portal'
	b'collaterals, varices and ascites'
	b'Fibroscan (transient elastography) median liver stiffness >12.5 kPa, the'
	b'Fibroscan must be performed by an experienced technician and interpreted by'
	b'the hepatologist'
	b'Platelet count <100 (x10^9/L) with no alternative cause'
	b'Absence of previous history or current suspicion of HCC - Absence of HCC is defined by'
	b'liver US, multiphase CT or contrast-enhanced MRI within 6 months prior to surveillance'
	b'Patient is able to comply with scheduled visits, evaluation plans and other study'
	b'procedures in the opinion of the investigator'
	b'Patient is willing to provide written informed consent'
Exclusion Criteria
	b'Contraindications to MRI scan (defibrillator, pacemaker, metallic foreign body, severe'
	b'claustrophobia etc.)'
	b'Contraindications to gadolinium'
	b'Age above 85 years old or younger than 20 years old'
	b'Pregnancy or breast feeding'
	b'Any other condition which, in the opinion of the Investigator, would make the patient'
	b'unsuitable for enrolment for the trial or could interfere with the completion of the'
	b'tudy'

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

hepatocellular carcinoma

liver cancer

liver mri

contrast-enhanced magnetic resonance imaging

liver ultrasound

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

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