Comparing MRI and Ultrasound for Liver Cancer Surveillance in Cirrhotic Patients
HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
This study is testing whether a new type of MRI can find liver cancer better than regular ultrasound in cirrhotic patients who have trouble with ultrasound imaging.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 476 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | Concord Repatriation General Hospital Academic / other |
| Locations | 10 sites (Camperdown, New South Wales and 9 other locations) |
| Trial ID | NCT04455932 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of abbreviated non-contrast MRI (aNC-MRI) compared to traditional ultrasound surveillance in cirrhotic patients who have poor ultrasound visualization. The research focuses on patients at risk for hepatocellular carcinoma (HCC), as current ultrasound methods often fail to detect early-stage cancers. By conducting a prospective analysis, the study seeks to identify a more reliable surveillance tool for this vulnerable population. The goal is to improve early detection rates of HCC, which is crucial for successful treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are cirrhotic patients who have experienced reduced visualization of their liver on ultrasound.
Not a fit: Patients with cirrhosis who have adequate ultrasound visualization or those with obscure causes of cirrhosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective surveillance method for early detection of liver cancer in patients with cirrhosis.
How similar studies have performed: While there is limited data on the specific use of aNC-MRI for this purpose, similar studies have shown promise in improving cancer detection rates using advanced imaging techniques.
Eligibility criteria
Show full inclusion / exclusion 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
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
Where this trial is running
Camperdown, New South Wales and 9 other locations
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Not_yet_recruiting)
- Concord Repatriation General Hospital — Concord, New South Wales, Australia (Recruiting)
- Gosford Hospital — Gosford, New South Wales, Australia (Not_yet_recruiting)
- Prince of Wales Hospital — Randwick, New South Wales, Australia (Not_yet_recruiting)
- Westmead Hospital — Westmead, New South Wales, Australia (Not_yet_recruiting)
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (Not_yet_recruiting)
- St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (Not_yet_recruiting)
- Austin Hospital — Heidelberg, Victoria, Australia (Not_yet_recruiting)
- Royal Perth Hospital — Perth, Western Australia, Australia (Not_yet_recruiting)
- North Shore Hospital — Takapuna, Auckland, New Zealand (Not_yet_recruiting)
Study contacts
- Principal investigator: Jessica Yang, MBBS — Concord Repatriation General Hospital
- Study coordinator: Jessica Yang, MBBS
- Email: jessica.yang1@health.nsw.gov.au
- Phone: +61297676495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.