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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06876805
Acronym
InFoLIL
Enrollment
100
Registered
2025-03-14
Start date
2024-08-01
Completion date
2027-04-01
Last updated
2025-03-14

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

Conditions

Focal Liver Lesion

Keywords

CEUS, Ultrasound, Liver, HCC

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.

Interventions

CEUS performed as normal clinical practice

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
CEUS diagnostic accuracy2 yearsCEUS diagnostic accuracy in determining the nature of focal liver lesions

Countries

Italy

Contacts

Primary ContactCarla Serra, PhD
carla.serra@aosp.bo.it+390512143270

Outcome results

None listed

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