Improving Hepatocellular Carcinoma Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI.
- Who it may be relevant to
- Registry conditions: Magnetic Resonance Imaging, Hepatocellular Carcinoma, Screening, Contrast-enhanced US. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Comparison of Diagnostic Performance and Cost-effectiveness of US and Abbreviated MRI for Hepatocellular Carcinoma Screening
Overview
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.
Interventions
- Device MRI
To compare the diagnostic performance of US+/- Constrast-enhanced US and AMRI for HCC detection in an at-risk population
Primary outcome measures
- 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.]
Secondary outcome measures (5)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Switzerland · 1 center
- Lausanne University Hospital — Lausanne
Identifiers
NCT: NCT05828446 · CER-VD 2022-D0116