Fast-MRI to improve liver cancer surveillance in high-risk patients
Official title: 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
Run by Assistance Publique - Hôpitaux de Paris · NCT05095714 · Data updated 2026-11-12
This trial will test whether adding a fast liver MRI to the routine six-month ultrasound finds early liver cancers sooner in adults with cirrhosis who have an annual HCC risk above 3%.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 944 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Bondy) |
| Status | Recruiting |
| Started | November 23, 2022 |
| Main results expected | November 23, 2028 |
| Study ends | June 23, 2030 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT05095714 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with proven or strongly suspected cirrhosis who have been in a surveillance program for at least six months, are Child-Pugh A or B, have an estimated annual HCC risk >3%, and can undergo MRI are ideal candidates.
✕Probably not a fit
Patients with Child-Pugh C disease, active/uncontrolled HBV or HCV, estimated annual HCC risk <3%, contraindications to MRI, non-echogenic livers, or who are pregnant/breastfeeding are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, multicenter, two-arm superiority trial enrolling adults with cirrhosis and an estimated annual HCC risk >3%. Participants are randomized 1:1 to semi-annual liver ultrasound alone (control) or semi-annual ultrasound plus a fast (abbreviated) liver MRI (experimental). If either imaging detects a nodule, participants undergo standard characterization with contrast imaging and/or biopsy and multidisciplinary review to establish a definitive HCC diagnosis. The primary comparison is the rate of very early (BCLC 0) HCC detected between the two arms, analyzed by intention-to-treat, with a parallel medico-economic analysis from the healthcare system perspective.
Why it matters
Potential benefit: If successful, adding fast-MRI could increase detection of very early HCC and enable more patients to receive curative treatments such as resection or ablation.
How similar studies have gone: Previous observational and smaller studies show MRI-based surveillance is more sensitive than ultrasound for detecting early HCC, but large randomized data specifically using abbreviated/fast-MRI are limited.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Assistance Publique Hôpitaux de Paris - Hôpital Avicenne
Bondy, France Recruiting
Study contacts
- Study coordinator: Pierre NAHON, MD, PhD
- Email: pierre.nahon@aphp.fr
- Phone: 1 48 02 62 80
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.