NCT04455932Recruiting
HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
Source: ClinicalTrials.gov · Last updated 8 Sept 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 476 (estimated)
- First submitted
- 27 Jun 2020
- Start date
- Jan 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Concord Repatriation General Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04455932
What you commit to
- Study type: Interventional
- Planned participants: 476
- From Jan 2022 to the primary completion date, Dec 2026
- 10 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Age
- Age above 85 years old or younger than 20 years old
Other
- Contraindications to MRI scan (defibrillator, pacemaker, metallic foreign body, severe claustrophobia etc.)
- Contraindications to gadolinium
- Pregnancy or breast feeding
Who the study is looking for
- 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
Age in the registry: 20 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Not yet recruiting |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Not yet recruiting |
| Concord Repatriation General Hospital Coordinator of this site? Confirm its status | Concord | Australia | Recruiting |
| St Vincent's Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Not yet recruiting |
| Gosford Hospital Coordinator of this site? Confirm its status | Gosford | Australia | Not yet recruiting |
| Austin Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Not yet recruiting |
| Royal Perth Hospital Coordinator of this site? Confirm its status | Perth | Australia | Not yet recruiting |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Not yet recruiting |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Not yet recruiting |
| North Shore Hospital Coordinator of this site? Confirm its status | Takapuna | New Zealand | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.