Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
décembre 2021
décembre 2027
29 août 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE HOSPITALIER SUD FRANCILIEN | NAHON Pierre | 18/10/2025 09:49:57 | Contacter | ||
| CHI DE CRETEIL | NAHON Pierre | 18/10/2025 09:49:58 | Contacter | ||
| HOPITAL FOCH | SOPHIE HILLAIRE | 20/10/2025 07:26:33 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/10/2025 09:49:59 | Contacter | |||
| AP-HP - Hôpital Avicenne | |||||
| AP-HP - Hôpital Beaujon | |||||
| AP-HP - Hôpital Cochin | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Paul Brousse | |||||
| AP-HP - Hôpital Saint Antoine | |||||
Critères
Tous
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
- 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
- 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)