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

NCT05772403 | Completed

• 1 other identifier: 4288
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• The role of CEUS in evaluating atypic liver lesions on contrast-enhanced CT or MRI.

  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.

  Between January 2018 and January 2023

Interventions

CEUS DIAGNOSTIC_TEST

CEUS for atypical liver nodules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed for liver cirrhosis or chronic liver disease with increased risk of HCC (HBV-related hepatopathy or fibrosis F3) and diagnosed with liver atypical nodules on contrast-enhanced CT or MRI.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico A Gemelli Irccs

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: August 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

IT (1)