Contrast Enhanced Ultrasound (CEUS) in Atypical Liver Nodules in Patients With Chronic Liver Disease

Last updated: March 20, 2023
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Completed

Phase

N/A

Condition

Digestive System Neoplasms

Abdominal Cancer

Liver Disease

Treatment

N/A

Clinical Study ID

NCT05772403
4288
  • Ages > 18
  • All Genders

Study Summary

The present study aims to investigate the role of CEUS in evaluating liver lesions with atypical characteristics on contrast-enhanced CT or MRI. All patients enrolled in the study underwent contrast-enhanced ultrasound. Based on CEUS characteristics, atypical nodules will be categorized according to CEUS LI-RADS classification.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • diagnosis of liver cirrhosis or chronic liver disease with increased risk of HCC
  • diagnosis of atypical nodules on contrast-enhanced CT or MRI

Exclusion

Exclusion Criteria:

  • less than 18 years of age
  • pregnancy
  • typical nodules on contrast-enhanced CT or MRI
  • non-visualized nodule on B-mode US
  • CEUS not performed or performed more than three months after CT or MRI

Study Design

Total Participants: 100
Study Start date:
August 01, 2021
Estimated Completion Date:
January 31, 2023

Study Description

This retrospective study investigates the role of CEUS in evaluating liver lesions with atypical characteristics on contrast-enhanced CT or MRI. All patients enrolled in the study underwent contrast-enhanced ultrasound. All CEUS exams were performed, recorded, and analyzed by two experienced operators (>10 years of experience with abdominal US and CEUS). Based on CEUS characteristics, atypical nodules will be categorized according to CEUS LI-RADS (LR) classification. If the analyzed nodule shows a typical hallmark on CEUS (LR-5), that is arterial phase hyperenhancement with late-onset (>60 s) washout of mild intensity, it is definitively considered HCC and have been treated appropriately. Categories LR-3 and LR-4 comprise nodules with different combinations of arterial and venous phase enhancement features, expected to correspond to an intermediate or high probability of lesions to be HCC. Patients with LR-3 or LR-4 nodules underwent follow-up; in some cases they underwent biopsy.

LR-M is used to classify high-probability malignant lesions but nonspecific for HCC; these nodules underwent biopsy for further characterization.

Connect with a study center

  • Fondazione Policlinico A Gemelli Irccs

    Roma, RM 00168
    Italy

    Site Not Available

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