An observational study in Hepatocellular Carcinoma, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
The present study aims to investigate the role of CEUS in evaluating liver lesions with atypical characteristics on contrast-enhanced CT or MRI. All patients enrolled in the study underwent contrast-enhanced ultrasound. Based on CEUS characteristics, atypical nodules will be categorized according to CEUS LI-RADS classification.
This retrospective study investigates the role of CEUS in evaluating liver lesions with atypical characteristics on contrast-enhanced CT or MRI. All patients enrolled in the study underwent contrast-enhanced ultrasound. All CEUS exams were performed, recorded, and analyzed by two experienced operators (>10 years of experience with abdominal US and CEUS). Based on CEUS characteristics, atypical nodules will be categorized according to CEUS LI-RADS (LR) classification. If the analyzed nodule shows a typical hallmark on CEUS (LR-5), that is arterial phase hyperenhancement with late-onset (>60 s) washout of mild intensity, it is definitively considered HCC and have been treated appropriately. Categories LR-3 and LR-4 comprise nodules with different combinations of arterial and venous phase enhancement features, expected to correspond to an intermediate or high probability of lesions to be HCC. Patients with LR-3 or LR-4 nodules underwent follow-up; in some cases they underwent biopsy.
LR-M is used to classify high-probability malignant lesions but nonspecific for HCC; these nodules underwent biopsy for further characterization.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 100 is below the median of 167 across 681 observational studies indexed under Liver Diseases.
Browse Liver Diseases studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
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Patients followed for liver cirrhosis or chronic liver disease with increased risk of HCC (HBV-related hepatopathy or fibrosis F3) and diagnosed with liver atypical nodules on contrast-enhanced CT or MRI.
Exclusion Criteria:
CEUS for atypical liver nodules
The role of CEUS in evaluating atypic liver lesions on contrast-enhanced CT or MRI.
The primary endpoint is to assess the contrastographic behaviour of nodules suspected of HCC and defined as atypical by contrast-enhanced CT and MRI, using CEUS. Prevalence of CEUS LI-RADS categories among atypical nodules will be described.
Time frame: Between January 2018 and January 2023
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS