RecruitingNot ApplicableNCT05828446

Improving Hepatocellular Carcinoma Screening

Prospective Comparison of Diagnostic Performance and Cost-effectiveness of US and Abbreviated MRI for Hepatocellular Carcinoma Screening


Sponsor

Naik Vietti Violi

Enrollment

330 participants

Start Date

Apr 1, 2023

Study Type

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

Min Age: 18 Years

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

DEVICEMRI

To compare the diagnostic performance of US+/- Constrast-enhanced US and AMRI for HCC detection in an at-risk population


Locations(1)

Lausanne University Hospital

Lausanne, Canton of Vaud, Switzerland

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NCT05828446


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