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临床试验/NCT03872362
NCT03872362已完成不适用

Radiomics and Clinical Variables Can Differentiate Malignant Nodules and Detect Invasive Adenocarcinoma in Pulmonary Nodules: a Multi-center Study

Maastricht University1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2018年7月11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
800
试验地点
1
主要终点
Malignant nodules classifier

研究概览

简要总结

The investigators aim to investigate the utility of radiomics to differentiate malignant nodules from benign nodules and invasive adenocarcinoma from non-invasive adenocarcinoma.

详细描述

With the development of computed tomography (CT) equipment and the increasing use of lung cancer screening programs with low-dose CT, a growing number of early-stage lung cancers were detected so that a large number of patients have undergone surgery.

Although a number of radiological studies have been used morphological signs so-called semantic features to make a differential diagnosis, it is still hard to apply by clinician because pulmonary nodules especially ground-glass nodules and small size nodules have atypical radiology signs and have strong subjectivity from different observers. Recently, CT-based radiomics, extracting the quantitative high-throughput features from medical images and facilitating clinical decision-making system, showed a good performance to predict diagnosis and prognosis of diverse cancer.

Therefore, the proposed project aims to develop and validate radiomics models based on CT images to identify malignant nodules and then to discriminate the different types of lung adenocarcinoma in patients with pulmonary nodules.

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

  • intraoperative frozen section diagnosis and final pathology diagnosis are available
  • preoperative standard non-enhanced CT is available
  • Pathologically confirmed

排除标准

  • with a previous history of radiation therapy, chemotherapy or biopsy
  • the time interval between the CT examination and surgery was more than two weeks

结局指标

主要结局

Malignant nodules classifier

时间窗: 30 days

Model based on Radiomic that can differentiate malignant nodules from benign nodules.

Invasive adenocarcinoma classifier

时间窗: 30 days

Model based on Radiomic that can differentiate invasive adenocarcinoma from non-invasive adenocarcinoma.

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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