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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Focal Liver Lesion

Treatments: Diagnostic Test: CEUS or Contrast enhanced Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT06876805

InFoLIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Group 1

Description:

Patients with focal liver lesions indeterminated at II level imaging methods

Treatment:

Diagnostic Test: CEUS or Contrast enhanced Ultrasound