Magnetic Resonance ImagingAMRIKNCT05828446
Improving Hepatocellular Carcinoma Screening
A study testing MRI in people with Magnetic Resonance Imaging and Hepatocellular Carcinoma, run by Naik Vietti Violi at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Resonance Imaging, Hepatocellular Carcinoma, Screening
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospital
Lausanne, Canton of Vaud, 1011
Naik Vietti Violi, MD, +41795560240, naik.vietti-violi@chuv.ch
Naik Vietti Violi, MD
About this study
Official title: Prospective Comparison of Diagnostic Performance and Cost-effectiveness of US and Abbreviated MRI for 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.
- Being tested
- MRI
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Also called Constrast-enhanced US
To compare the diagnostic performance of US+/- Constrast-enhanced US and AMRI for HCC detection in an at-risk population
| Study group | Role | What they receive |
|---|---|---|
| HCC screening population according to European Association for the Study of the Liver recommendation | Experimental | Not described Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (5)
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)
Measured: 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:
- No discomfort
- Low discomfort
- Neutral
- Comfort
- high comfort
Measured: 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.
Measured: 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
Measured: 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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Apr 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single center interventional prospective study
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naik Vietti Violi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naik Vietti Violi, University of Lausanne Hospitals
- Investigators
- Naik Vietti Violi, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828446
- Sponsor's protocol ID
- CER-VD 2022-D0116
- Acronym
- AMRIK
- Status last verified
- Mar 2025
- First submitted
- 19 Jan 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Diagnostic Performance and Cost-effectiveness of US and Abbreviated MRI for Hepatocellular Carcinoma Screening
- ClinicalTrials.gov ID
- NCT05828446
- Acronym / sponsor ID
- AMRIK / CER-VD 2022-D0116
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Naik Vietti VioliUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single center interventional prospective study
| Arm | Type | Receives |
|---|---|---|
| HCC screening population according to European Association for the Study of the Liver recommendation | Experimental | Device: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- History of HCC
- History of other malignancy
- Prior liver nodule categorized as LI-RAD 4, 5 or M
- History of liver transplantation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: Constrast-enhanced USTo compare the diagnostic performance of US+/- Constrast-enhanced US and AMRI for HCC detection in an at-risk population | Device | HCC screening population according to European Association for the Study of the Liver recommendation |
Primary outcome
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.
5 secondary outcomes
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.
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
To develop and test a DL model for HCC detection based on AMRI.
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.
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.
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Magnetic Resonance Imaging
Enrolling by invitation
Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods
Healthy
Not yet recruiting
Salience Network Informed rTMS for PTSD
Stress Disorders, Post-Traumatic
Not yet recruiting
Non-Invasive Vagus Nerve Stimulation as a Probe to Map Functional Connectivity in Schizophrenia Using Functional Magnetic Resonance Imaging
Schizophrenia Spectrum Disorders
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Recruiting
Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
Pancreatic Steatosis, Pancreatic Cyst
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naik Vietti Violi, MD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Magnetic Resonance Imaging and Hepatocellular Carcinoma, run by Naik Vietti Violi at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naik Vietti Violi, MD (+41213144556, naik.vietti-violi@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.