Actively Recruiting
FAST-IRM for HCC suRveillance in pAtients With High risK of Liver Cancer.
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-12
944
Participants Needed
1
Research Sites
395 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FAST-IRM for HCC suRveillance in pAtients With High risK of Liver Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Enrolled in a liver cancer screening program for at least 6 months in a tertiary hepatology center
- Cirrhosis confirmed by biopsy or clear non-invasive tests
- No hepatocellular carcinoma detected on imaging within the last 3 months
- Liver tissue can be examined by ultrasound
- Child-Pugh score A or B
- Cirrhosis caused by non-viral factors or controlled/healed hepatitis B or C infection
- Estimated annual risk of hepatocellular carcinoma greater than 3%
- Provided written informed consent
- Affiliated with a social security system
You will not qualify if you...
- Child-Pugh score C
- Active hepatitis B or C infection
- Estimated annual risk of hepatocellular carcinoma less than 3%
- Not previously enrolled in a screening program
- Contraindications to Fast-MRI
- Liver tissue not visible by ultrasound
- Patient deprived of liberty
- Patient under legal protection
- Pregnant or breastfeeding
- Patient receiving state medical aid (AME)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Assistance Publique Hôpitaux de Paris - Hôpital Avicenne
Bondy, France, 93140
Actively Recruiting
Research Team
P
Pierre NAHON, MD, PhD
CONTACT
D
David SCHMITZ
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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