Improving Hepatocellular Carcinoma Screening (AMRIK)

March 31, 2025 updated by: Naik Vietti Violi

Prospective Comparison of Diagnostic Performance and Cost-effectiveness of US and Abbreviated MRI for Hepatocellular Carcinoma Screening

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Recruiting
        • Lausanne University Hospital
        • Contact:
        • Contact:
          • Naik Vietti Violi, MD
        • Contact:
          • Clarisse Dromain, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCC screening population according to European Association for the Study of the Liver recommendation
Device: MRI
To compare the diagnostic performance of US+/- Constrast-enhanced US and AMRI for HCC detection in an at-risk population
Other Names:
  • Constrast-enhanced US

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the diagnostic performance of US+/- CEUS and AMRI for HCC detection in an at-risk population
Time Frame: Through study completion, an average of 1 year.

The patients will undergo all the normal follow-up according to clinical recommendations, consisting of a bi-annual clinical visit in the gastro-enterology department and an US. The US will be followed by CEUS in case of suspicious lesion. On the same week, the study participants will undertake MRI.

The data of the full MRI will be used to reconstruct two different AMRI sets for reading: non-contrast (NC-) and dynamic (Dyn-) AMRI.

The endpoint is the rate of HCC detection. Outcome measures will be compared in terms of ROC curve and AUC.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the patient-level accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of US +/- CEUS vs. AMRI for HCC.
Time Frame: Through study completion, an average of 1 year.

Diagnostic performance of the different tests [(1)US alone, (2) US + CEUS, (3) NC-AMRI, (4) Dyn-AMRI] will be compared using all patient information (including complete MRI and pathology) as the reference standard.

Outcome measures will be compared in terms accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)
Through study completion, an average of 1 year.
To develop and test a DL model for HCC detection based on AMRI.
Time Frame: Through study completion, an average of 1 year.
AMRI DL based model will be analysed in terms of (1) diagnostic performance (ROC, AUC, sensitivitiy, specificity, accuracy) and (2) time savings compared to AMRI read by a radiologist.
Through study completion, an average of 1 year.
To perform a cost-effectiveness analysis comparing US to different alternative screening strategies for HCC in Switzerland.
Time Frame: Through study completion, an average of 1 year.

Cost effectiveness analysis will be perfomed by building a model using all study data: patient characteristics, exam diagnostic performance and patient management costs.

Outcome will be analysed in terms of Lifetime costs, quality adjusted life expectancy
Through study completion, an average of 1 year.
To perform a cost-effectiveness analysis comparing US to different alternative screening strategies for HCC in Switzerland.
Time Frame: Through study completion, an average of 1 year.

Cost effectiveness analysis will be perfomed by building a model using all study data: patient characteristics, exam diagnostic performance and patient management costs.

Outcome will be analysed in terms of incremental costs effectiveness ratios.
Through study completion, an average of 1 year.
Evaluate patient satisfaction and comfort with US +/- CEUS vs. AMRI with a questionnaire
Time Frame: Once, after the first screening round (US+/-CEUS and MRI), 6 months

In order to evaluation patient's opinion a survey regarding patient experience and opinion to the different test will be performed.

Outcome will be measured in term of level of confort using a 5-scale score: from low discomfort to high discomfort:

  1. No discomfort
  2. Low discomfort
  3. Neutral
  4. Comfort
  5. high comfort
Once, after the first screening round (US+/-CEUS and MRI), 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Naik Vietti Violi

Investigators

  • Principal Investigator: Naik Vietti Violi, MD, University of Lausanne Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER-VD 2022-D0116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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