Fast-MRI to improve liver cancer surveillance in high-risk patients

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 944 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Bondy)
• Trial ID: NCT05095714 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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)

Where this trial is running

Bondy

• Assistance Publique Hôpitaux de Paris - Hôpital Avicenne — Bondy, France (RECRUITING)

Study contacts

• Study coordinator: Pierre NAHON, MD, PhD

Conditions: Hepatocellular Carcinoma, Liver Cancer, Cirrhosis, Chronic Liver Disease, Hepatocellular carcinoma, Liver cancer, Chronic liver disease, Surveillance