RecruitingNot ApplicableNCT05095714

FAST-IRM for HCC suRveillance in pAtients With High risK of Liver Cancer.

Randomized Study Evaluating the Cost Impact and Effectiveness of Systematic Liver Fast-MRI Surveillance for Early-stage Hepatocellular Carcinoma in High-risk Patients Included in Ultrasound Surveillance Programs


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

944 participants

Start Date

Nov 23, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Intro: Hepatocellular carcinoma (HCC) is the 6th leading cause of cancer worldwide. In France, more than 10,000 new cases are identified each year. The latter occur in 85% of cases in cirrhosis, the most frequent causes of which are excessive alcohol consumption, metabolic syndrome or HBV/HCV infection. Patients with cirrhosis justify being included in monitoring programs involving the performance of a semi-annual liver ultrasound (US) in order to detect HCC eligible for curative treatment (liver resection or percutaneous ablation). This practice is considered to be cost-effective in the event of an annual incidence of HCC\> 1.5%. US in this context has a low sensitivity for the detection of HCC at the very early stage and the following observations have been made in the last 20 years: * The rate of patients detected at early stage BCLC 0 is around 30% by ultrasound * The rate of patients included in surveillance programs detected with advanced HCC eligible for palliative treatment is around 20% * Reducing the periodicity of liver ultrasounds from 6 to 3 months does not improve these results. In parallel, liver MRI has been evaluated as a tool for the early detection of HCC. Its performance for the detection of HCC at the very early stage exceeds 80%. However, due to the higher cost compared to US, it was estimated that its use in screening context would only be cost effective in the event of an annual incidence\> 3%. In addition, the practice of these expensive and long-lasting MRIs (30 to 45 minutes) can be optimized by carrying out abbreviated MRI protocols" or Fast-MRI: short protocols (\<10 minutes), based on the sequences with the better detection sensitivities (Se\> 83%). The hypothesis is that Fast-MRI used as a screening examination in patients at high risk of HCC (\> 3% per year) could increase the rates of patients detected at an early stage accessible to curative treatment and demonstrate its cost-effectiveness in this population. Hypothesis/Objective: The main objective is to assess the cost / QALY and / patient detected with an early HCC BCLC 0 (single tumor \<2cm) by semi-annual monitoring by liver US and Fast-MRI, compared to conventional semi-annual monitoring by liver US alone in patients with cirrhosis and an anticipated HCC incidence\>3%. Conclusion: If positive, this trial could modify international practice guidelines and set MRI as the optimal tool for early HCC detection in high-risk patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing fast MRI scans to standard ultrasound for detecting liver cancer (hepatocellular carcinoma) in people with cirrhosis (serious liver scarring). The goal is to find out whether MRI can catch liver cancer earlier and more reliably than ultrasound in high-risk patients. **You may be eligible if...** - You are 18 or older - You have cirrhosis (confirmed by biopsy or non-invasive tests) at a liver center - You are already enrolled in a liver cancer surveillance program for at least 6 months - Your annual risk of developing liver cancer is above 3% - Your cirrhosis is from viral hepatitis B or C that is treated/cured, or from non-viral causes - You are classified as Child-Pugh A or B (a measure of liver function) **You may NOT be eligible if...** - You have Child-Pugh C liver disease (most severe stage) - You have active hepatitis B or C - You have any contraindication to MRI - You are not visible by ultrasound - You are pregnant or breastfeeding - You are on state medical aid (AME in France) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLiver ultrasound and fast-MRI

Half-yearly liver ultrasound and fast-MRI

OTHERLiver ultrasound

Half-yearly liver ultrasound


Locations(1)

Assistance Publique Hôpitaux de Paris - Hôpital Avicenne

Bondy, France

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NCT05095714


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