Improving Hepatocellular Carcinoma Screening
Prospective Comparison of Diagnostic Performance and Cost-effectiveness of US and Abbreviated MRI for Hepatocellular Carcinoma Screening
Naik Vietti Violi
330 participants
Apr 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria8
- 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
Interventions
To compare the diagnostic performance of US+/- Constrast-enhanced US and AMRI for HCC detection in an at-risk population
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05828446