An interventional study of MRI in Magnetic Resonance Imaging, Hepatocellular Carcinoma and Screening, sponsored by Naik Vietti Violi. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Naik Vietti Violi · Not applicable, Interventional, and 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.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 330 is above the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Naik Vietti Violi is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: MRI
To compare the diagnostic performance of US+/- Constrast-enhanced US and AMRI for HCC detection in an at-risk population
Also known as: Constrast-enhanced US
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.
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.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Naik Vietti Violi