NCT06876805

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

The Role of Contrast Enhanced Ultrasond (Ceus), in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Focal Liver Lesion

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CEUS or Contrast enhanced Ultrasound	CEUS performed as normal clinical practice

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2027-04-01
• First posted: 2025-03-14
• Last updated: 2025-03-14

Locations

1 site across 1 country: Italy