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临床试验/NCT04816981
NCT04816981已完成不适用

Clinical Utility of Artificial Intelligence-Augmented Endobronchial Ultrasound-Elastography in Lymph Node Staging for Lung Cancer

St. Joseph's Healthcare Hamilton2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年9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
2
主要终点
Stiffness Area Ratio

研究概览

简要总结

Before any treatment decisions are made for patients with lung cancer, it is crucial to determine whether the cancer has spread to the lymph nodes in the chest. Traditionally, this is determined by taking biopsy samples from these lymph nodes, using the Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) procedure. Unfortunately, in 40% of the time, the results of EBUS-TBNA are not informative and wrong treatment decisions are made. There is, therefore, a recognized need for a better way to determine whether the cancer has spread to the lymph nodes in the chest. The investigators believe that elastography, a recently discovered imaging technology, can fulfill this need. In this study, the investigators are proposing to determine whether elastography can diagnose cancer in the lymph nodes. Elastography determines the tissue stiffness in the different parts of the lymph node and generates a colour map, where the stiffest part of the lymph node appears blue, and the softest part appears red. It has been proposed that if a lymph node is predominantly blue, then it contains cancer, and if it is predominantly red, then it is benign. To study this, the investigators have designed an experiment where the lymph nodes are imaged by EBUS-Elastography, and the images are subsequently analyzed by a computer algorithm using Artificial Intelligence. The algorithm will be trained to read the images first, and then predict whether these images show cancer in the lymph node. To evaluate the success of the algorithm, the investigators will compare its predictions to the pathology results from the lymph node biopsies or surgical specimens.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Patients that are diagnosed with suspected or confirmed NSCLC that have been referred to mediastinal staging through EBUS-TBNA at St. Joseph's Healthcare Hamilton will be eligible for this study.

排除标准

  • No exclusion criteria will apply.

结局指标

主要结局

Stiffness Area Ratio

时间窗: 8 months

Identifying whether the percent area of a lymph node above a defined blue colour threshold is independently associated with malignancy

次要结局

  • NeuralSeg's prediction of lymph node malignancy(2 months)
  • The agreement between NeuralSeg's predictions and pathology results, as measured by diagnostic accuracy, sensitivity, specificity, positive and negative predictive values(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wael Hanna

Associate Professor

McMaster University

研究点 (2)

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