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

Contrast-enhanced Ultrasound (CEUS) Improves Characterization of Atypical Liver Nodules in Patients With Chronic Liver Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05772403

Enrollment

100

Registered

2023-03-16

Start date

2021-08-01

Completion date

2023-01-31

Last updated

2023-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTCEUS

CEUS for atypical liver nodules

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 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

Design outcomes

Primary

Measure	Time frame	Description
The role of CEUS in evaluating atypic liver lesions on contrast-enhanced CT or MRI.	Between January 2018 and January 2023	The primary endpoint is to assess the contrastographic behaviour of nodules suspected of HCC and defined as atypical by contrast-enhanced CT and MRI, using CEUS. Prevalence of CEUS LI-RADS categories among atypical nodules will be described.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026