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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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Assistance Publique Hôpitaux de Paris - Hôpital Avicenne
RECRUITING
Bondy
Contact Information
Primary
Pierre NAHON, MD, PhD
pierre.nahon@aphp.fr
1 48 02 62 80
Backup
David SCHMITZ
david.schmitz@aphp.fr
1 49 81 36 32
Time Frame
Start Date: 2022-11-23
Estimated Completion Date: 2030-06-23
Participants
Target number of participants: 944
Treatments
Experimental: Enhanced screening
Half-yearly liver ultrasound and fast-MRI
Active_comparator: Screening recommendations
Half-yearly liver ultrasound
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov