Improving Hepatocellular Carcinoma Screening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNaik Vietti Violi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of HCC
History of other malignancy
Prior liver nodule categorized as LI-RAD 4, 5 or M
History of liver transplantation
Trial design
Design model
Single group
Treatments tested in this trial
MRI
DeviceTo compare the diagnostic performance of US+/- Constrast-enhanced US and AMRI for HCC detection in an at-risk population
Treatment groups
330 Participants
are divided into 1 treatment groupGroup A: HCC screening population according to European Association for the Study of the Liver recommendationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To 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.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.
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.2
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 months3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Naik Vietti Violi
Lead sponsor
University of Lausanne Hospitals
Sponsor institution
Source ClinicalTrials.gov