AMRIK: Improving Hepatocellular Carcinoma Screening

Sponsor
Naik Vietti Violi (Other)
Overall Status
Recruiting
CT.gov ID
NCT05828446
Collaborator
(none)
330
1
1
49
6.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MRI
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
330 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
single center interventional prospective studysingle center interventional prospective study
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Prospective Comparison of Diagnostic Performance and Cost-effectiveness of US and Abbreviated MRI for Hepatocellular Carcinoma Screening
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2026
Anticipated Study Completion Date :
Apr 30, 2027

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. To compare the diagnostic performance of US+/- CEUS and AMRI for HCC detection in an at-risk population [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 Outcome Measures

    1. Compare the patient-level accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of US +/- CEUS vs. AMRI for HCC. [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 [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.

    3. To develop and test a DL model for HCC detection based on AMRI. [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. [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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lausanne University Hospital Lausanne Vaud Switzerland 1011

    Sponsors and Collaborators

    • Naik Vietti Violi

    Investigators

    • Principal Investigator: Naik Vietti Violi, MD, Lausanne University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Naik Vietti Violi, Radiologist, Principal investigator, University of Lausanne Hospitals
    ClinicalTrials.gov Identifier:
    NCT05828446
    Other Study ID Numbers:
    • CER-VD 2022-D0116
    First Posted:
    Apr 25, 2023
    Last Update Posted:
    Apr 25, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 25, 2023