Prospective Comparison of Diagnostic Performance and Cost-effectiveness of US and Abbreviated MRI for Hepatocellular Carcinoma Screening
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 330
- Locations
- 2
- Primary Endpoint
- To compare the diagnostic performance of US+/- CEUS and AMRI for HCC detection in an at-risk population
Study Overview
Brief 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). 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- To develop and test a DL model for HCC detection based on AMRI.(Through study completion, an average of 1 year.)
- Evaluate patient satisfaction and comfort with US +/- CEUS vs. AMRI with a questionnaire(Once, after the first screening round (US+/-CEUS and MRI), 6 months)
- Compare the patient-level accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of US +/- CEUS vs. AMRI for HCC.(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.(Through study completion, an average of 1 year.)
Investigators
Naik Vietti Violi
Radiologist, Principal investigator
University of Lausanne Hospitals