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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2027-04-01

Brief Summary

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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.

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Detailed Description

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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

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Focal Liver Lesion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients with focal liver lesions indeterminated at II level imaging methods

CEUS or Contrast enhanced Ultrasound

Intervention Type DIAGNOSTIC_TEST

CEUS performed as normal clinical practice

Interventions

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CEUS or Contrast enhanced Ultrasound

CEUS performed as normal clinical practice

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Contrast enhanced ultrasound

Eligibility Criteria

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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.