Improving Hepatocellular Carcinoma Screening (AMRIK)

Naik Vietti Violi

Status: Enrolling

Conditions: Screening; Contrast-enhanced US; Hepatocellular Carcinoma; Magnetic Resonance Imaging

Treatments: Device: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT05828446

CER-VD 2022-D0116

Details and patient eligibility

About

This is a monocentric, single blind, interventional, single arm study. It is designed to compare the rates of detection of hepatocellular carcinoma (HCC) by ultrasound (US) used in clinical routine vs. abbreviated magnetic resonance imaging (AMRI). The hypothesis is that dynamic AMRI with extracellular contrast agent injection has a higher patient-level detection rate of HCC than screening US and non-contrast AMRI.

Interested and eligible patients will be enrolled and undergo HCC screening rounds including US +/- contrast-enhanced US (clinical routine) and screening MRI within the same week bi-annually.

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult patients with chronic liver disease and indication for HCC screening according to the European Association for the Study of the Liver recommendations.
• Informed Consent signed by the subject

Exclusion criteria

• History of HCC
• History of other malignancy
• Prior liver nodule categorized as LI-RAD 4, 5 or M
• History of liver transplantation
• Pregnancy
• MRI or MRI contrast agent precaution
• Any other condition making the patient unsuitable for the study
• Patient's refusal of transmission of relevant medical conditions found on the medical examinations performed during the study

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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330 participants in 1 patient group

HCC screening population according to European Association for the Study of the Liver recommendation

Experimental group

Treatment:

Device: MRI