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NCT Number: NCT06876805

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

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Carla Serra, PhD

CONTACT

[email protected]

+390512143270

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CEUS or Contrast enhanced Ultrasound

Diagnostic Test

CEUS performed as normal clinical practice

Other names: Contrast enhanced ultrasound

Primary outcomes

  1. CEUS diagnostic accuracy

    Time frame: 2 years

    CEUS diagnostic accuracy in determining the nature of focal liver lesions

Study contacts

Contact information is provided by the study sponsor or research team.

Carla Serra, PhD

CONTACT

[email protected]

+390512143270

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: InFoLIL

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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