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

Condition(s) studied

Investigational drug(s) / intervention(s)

Liver ultrasound and fast-MRI: Half-yearly liver ultrasound and fast-MRI

Liver ultrasound: Half-yearly liver ultrasound

Study 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

Primary outcome measure(s)

• Incremental cost / QALY ratio — at 36 months
  Medico-economic efficiency criterion will assess the quality of life using the EQ-5D5L scale and compare their variations to the total costs evaluated for each arm.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition