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

NCT05095714 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 944

Last updated 2026-03-12

No results posted yet for this 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.

Conditions

Interventions

OTHER

Liver ultrasound and fast-MRI

Half-yearly liver ultrasound and fast-MRI

OTHER

Liver ultrasound

Half-yearly liver ultrasound

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Pierre NAHON, MD, PhD · Assistance Publique Hôpitaux de Paris (AP-HP)

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-23
Primary Completion
2028-11-23
Completion
2030-06-23

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05095714 on ClinicalTrials.gov