NCT05095714 FAST-IRM for HCC suRveillance in pAtients With High risK of Liver Cancer.
| NCT ID | NCT05095714 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 944 participants |
| Start Date | 2022-11-23 |
| Primary Completion | 2028-11-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 944 participants in total. It began in 2022-11-23 with a primary completion date of 2028-11-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Pierre NAHON, MD, PhD
STUDY DIRECTOR
Assistance Publique Hôpitaux de Paris (AP-HP)
Frequently Asked Questions
Who can join the NCT05095714 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05095714 currently recruiting?
Yes, NCT05095714 is actively recruiting participants. Contact the research team at pierre.nahon@aphp.fr for enrollment information.
Where is the NCT05095714 trial being conducted?
This trial is being conducted at Bondy, France.
Who is sponsoring the NCT05095714 clinical trial?
NCT05095714 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Pierre NAHON, MD, PhD at Assistance Publique Hôpitaux de Paris (AP-HP). The trial plans to enroll 944 participants.
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