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NCT Number: NCT05828446

Improving 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.

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Key information

Conditions

Magnetic Resonance Imaging Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Contrast-enhanced US Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Screening

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location status: Recruiting

Location contact

Clarisse Dromain, MD

SUB_INVESTIGATOR

Naik Vietti Violi, MD

CONTACT

[email protected]

+41795560240

Naik Vietti Violi, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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:

    • No discomfort
    • Low discomfort
    • Neutral
    • Comfort
    • high comfort

  3. 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.

  4. 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

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clarisse Dromain, MD

CONTACT

[email protected]

+41213144556

Naik Vietti Violi, MD

CONTACT

[email protected]

+41213144556

Sponsors and collaborators

Lead sponsor

Naik Vietti Violi

Other

Registry information

Official study title

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

Acronym: AMRIK

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 25, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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