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

NCT05095714 | Recruiting

• 1 other identifier: APHP210987
• Study Type: interventional
• Target: 944
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease; Hepatocellular Carcinoma; Liver Cancer; Cirrhosis

Keywords

Hepatocellular carcinoma; Liver cancer; Cirrhosis; Chronic liver disease; Surveillance; Detection; MRI; Risk stratification

Outcome Measures

Primary Outcomes (1)

• Incremental cost / QALY ratio

  Medico-economic efficiency criterion will assess the quality of life using the EQ-5D5L scale and compare their variations to the total costs evaluated for each arm.

  at 36 months

Secondary Outcomes (6)

• Percentage of HCC detected at early stage

  at 36 months

• Sensitivity

  at 36 months

• Specificity

  at 36 months

• Rates of curative HCC treatments

  at 36 months

• Survival

  at 36 months

Study Arms (2)

Enhanced screening

EXPERIMENTAL

Half-yearly liver ultrasound and fast-MRI

Other: Liver ultrasound and fast-MRI

Screening recommendations

ACTIVE COMPARATOR

Half-yearly liver ultrasound

Other: Liver ultrasound

Interventions

Liver ultrasound OTHER

Half-yearly liver ultrasound

Screening recommendations

Liver ultrasound and fast-MRI OTHER

Half-yearly liver ultrasound and fast-MRI

Enhanced screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - Hôpital Avicenne

Bondy, 93140, France

RECRUITING

Related Publications (1)

• Nahon P, Ronot M, Sutter O, Natella PA, Baloul S, Durand-Zaleski I, Audureau E. Study protocol for FASTRAK: a randomised controlled trial evaluating the cost impact and effectiveness of FAST-MRI for HCC suRveillance in pAtients with high risK of liver cancer. BMJ Open. 2024 Feb 17;14(2):e083701. doi: 10.1136/bmjopen-2023-083701.

  PMID: 38367972 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Fibrosis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre NAHON, MD, PhD

  Assistance Publique Hôpitaux de Paris (AP-HP)

  STUDY DIRECTOR

Central Study Contacts

Pierre NAHON, MD, PhD

CONTACT

1 48 02 62 80; pierre.nahon@aphp.fr

David SCHMITZ

CONTACT

1 49 81 36 32; david.schmitz@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 27, 2021
• Study Start: November 23, 2022
• Primary Completion (Estimated): November 23, 2028
• Study Completion (Estimated): June 23, 2030
• Last Updated: March 12, 2026

Record last verified: 2025-05

Locations

FR (1)