The Role of Ceus in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods

Recruiting

• Conditions: Focal Liver Lesion

• Registration Number: NCT06876805
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

The primary objective of the study is to determine the accuracy of CEUS in characterizing (as benign or malignant) focal liver lesions for which CT, MRI and/or PET have not been conclusive.

Detailed Description

The study conducted will be a non-profit, observational, non-pharmacological, cross-sectional, but also partly cohort, retrospective and prospective study. The study is cross-sectional in nature, but will require 6 months of follow-up to evaluate the gold standard reference outcome in patients diagnosed with a benign pathology that does not require further investigations, and in patients with suspected malignant lesion for which histological diagnosis has not been performed on biopsy.

Study Timeline

• Study Start: 2024-08-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-08-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age ≥18 years.
• CEUS performed performed in the last 6 months a CT, MRI and/or PET not decisive in characterizing a liver lesion.
• Obtaining informed consent.

Exclusion Criteria

• Technical impossibility to perform the ultrasound evaluation.
• Documented allergy to the ultrasound contrast medium.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CEUS diagnostic accuracy	2 years	CEUS diagnostic accuracy in determining the nature of focal liver lesions

Trial Locations

Locations (1)

Policlinico Sant'Orsola Malpighi; 🇮🇹 Bologna, Italy