Trial Information

Contrast Enhanced Ultrasound for the Evaluation of Focal Liver Lesions - a Multi-center Study on the Usefulness in the Clinical Practice

Focal liver lesions (FLL) are quite frequently discovered in daily practice at routine
ultrasound and sometimes require the use of extensive investigations for a correct
diagnosis, thus increasing the costs and duration of diagnosis. On the other hand, due to
screening strategies for patients with liver cirrhosis, FLL are discovered very early in
these patients, and they must be evaluated in order to establish a therapeutic strategy
(including transplantation, surgical resection or percutaneous echoguided procedures).

Contrast enhanced ultrasound (CEUS) using second generation contrast agents is a relatively
new imaging modality that allows the characterization of FLL and allows a positive diagnosis
based on the vascular pattern of the lesion. The advantages of this method are the low cost
as compared with other imaging modalities and the fact that it can be performed immediately
after standard abdominal ultrasound, so approximately 5 minutes after CEUS (the total
duration of this investigation) a confident diagnosis can be obtained.

The place of CEUS in the diagnostic algorithm of FLL is not very well established. The
European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) issued the
first Guidelines regarding the use of CEUS in 2004, revised in 2008, in which the main
indications of this method are presented.

The purpose of this study is to establish the value of CEUS in the evaluation of de novo FLL
in clinical practice.

The study will include patients discovered with de novo FLL at standard ultrasound in which
the ultrasound study is not conclusive for the positive diagnosis (the patients with simple
cysts or known FLL under CEUS follow up will be excluded form the study). The standard
ultrasound will be followed by the contrast study using SonoVue® (Bracco, Italy) as contrast
agent. The amount of contrast agent will be documented in every patient (it depends on the
ultrasound machine used and the suspected diagnosis). The examination will be performed
using the dedicated contrast software of each ultrasound machine used in the study. The
investigators shall also document in every patient: the indication for CEUS study, a short
history including the presence of chronic hepatopathies or malignancies, the ultrasound
machine used and the operator. Each examination will last about 5 min after bolus injection
and will be documented by 4 video files no longer than 30 seconds each, containing: The
standard study, the arterial phase, the portal phase and the late phase. Additional loops
can be stored whenever it is considered necessary.

A CEUS diagnosis will be established based on the contrast study. This will be compared with
the final diagnosis which will be established based on all available imaging and clinical
data: computer tomography, MRI, biopsy, follow up information. A CEUS examination will be
considered conclusive if, following contrast, the FLL had a typical enhancement pattern
according to the EFSUMB guidelines, and inconclusive if the enhancement pattern of the
lesions was not in concordance with this guide.

The stored loops will be also revised by different operators. The study design is
prospective, multi-center and will be approved by the ethical review board.