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

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Age ≥ 18 years
* Patient enrolled in a screening program for at least 6 months in a tertiary hepatology center
* Cirrhosis histologically proven or unequivocally suggested by non-invasive tests
* Absence of HCC on imaging less than 3 months o
* Liver parenchyma explorable by ultrasound
* Child-Pugh A or B
* Cirrhosis of non-viral or viral B/C cause controlled/healed
* With an estimated annual risk of HCC\>3%
* Written informed consent
* Affiliation to a social security system

Exclusion Criteria:

* Child-Pugh C score
* Active hepatitis B or C
* Estimated annual risk of HCC\<3%
* No prior enrollment in a screening program
* Contraindication to Fast-MRI
* Non-echogenic patient
* Patient deprived of liberty
* Patient under legal protection
* Pregnant or breastfeeding woman
* Patient on AME (state medical aid)

• DERIVEDNahon P, Ronot M, Sutter O, Natella PA, Baloul S, Durand-Zaleski I, Audureau E. Study protocol for FASTRAK: a randomised controlled trial evaluating the cost impact and effectiveness of FAST-MRI for HCC suRveillance in pAtients with high risK of liver cancer. BMJ Open. 2024 Feb 17;14(2):e083701. doi: 10.1136/bmjopen-2023-083701. PMID 38367972