The Role of Ceus in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CEUS or Contrast enhanced Ultrasound.
- Who it may be relevant to
- Registry conditions: Focal Liver Lesion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Role of Contrast Enhanced Ultrasond (Ceus), in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods
Overview
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
- Diagnostic test CEUS or Contrast enhanced Ultrasound
CEUS performed as normal clinical practice
Primary outcome measures
- CEUS diagnostic accuracy [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Policlinico Sant'Orsola Malpighi — Bologna
Identifiers
NCT: NCT06876805 · InFoLIL