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临床试验/NCT05772403
NCT05772403已完成不适用

Contrast-enhanced Ultrasound (CEUS) Improves Characterization of Atypical Liver Nodules in Patients With Chronic Liver Disease

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
The role of CEUS in evaluating atypic liver lesions on contrast-enhanced CT or MRI.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of liver cirrhosis or chronic liver disease with increased risk of HCC
  • diagnosis of atypical nodules on contrast-enhanced CT or MRI

排除标准

  • less than 18 years of age
  • pregnancy
  • typical nodules on contrast-enhanced CT or MRI
  • non-visualized nodule on B-mode US
  • CEUS not performed or performed more than three months after CT or MRI

结局指标

主要结局

The role of CEUS in evaluating atypic liver lesions on contrast-enhanced CT or MRI.

时间窗: Between January 2018 and January 2023

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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