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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
330
To compare the diagnostic performance of US+/- Constrast-enhanced US and AMRI for HCC detection in an at-risk population
Lausanne University Hospital
Lausanne, Canton of Vaud, Switzerland
RECRUITINGTo compare the diagnostic performance of US+/- CEUS and AMRI for HCC detection in an at-risk population
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.
Time frame: Through study completion, an average of 1 year.
Compare the patient-level accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of US +/- CEUS vs. AMRI for HCC.
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)
Time frame: Through study completion, an average of 1 year.
Evaluate patient satisfaction and comfort with US +/- CEUS vs. AMRI with a questionnaire
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
Time frame: Once, after the first screening round (US+/-CEUS and MRI), 6 months
To develop and test a DL model for HCC detection based on AMRI.
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.
Time frame: 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.
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
Time frame: 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.
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.
Time frame: Through study completion, an average of 1 year.
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