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临床试验/NCT07686562
NCT07686562已完成不适用

Evaluating the Real-World Performance of Artificial Intelligence (AI)-Based Detection for Interstitial Lung Disease in Chest X-Ray Images

Chung-Ang University Hospital1 个研究点 分布在 1 个国家目标入组 1,293 人开始时间: 2022年2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
1,293
试验地点
1
主要终点
Positive predictive value (PPV) of AI-detected interstitial opacity

研究概览

简要总结

The goal of this observational study is to learn how well an artificial intelligence (AI)-based chest X-ray analysis software can incidentally detect interstitial lung disease (ILD), which appears as interstitial opacity, on chest X-rays taken for other reasons, and whether these AI-flagged findings represent true interstitial opacity.

The main question it aims to answer is: How often does an AI-flagged interstitial opacity correspond to true ILD?

This retrospective study uses existing records: researchers review each participant's follow-up computed tomography(CT), CT report, and final diagnosis to confirm true ILD and reticular opacity.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 19 years or older
  • Visited the pulmonology and allergy clinic (outpatient or inpatient) at Chung-Ang University Hospital (Seoul or Gwangmyeong) and underwent chest radiography from January 2022 to December 2024
  • A follow-up CT performed after the index chest radiograph
  • Reticular/interstitial opacity detected on the index radiograph by VUNO Med®-Chest X-ray™

排除标准

  • Prior history of ILD or ILD-related disease before the index chest radiograph, or a CT report containing terms related to interstitial opacity
  • Non-frontal (non-posteroanterior/anteroposterior [PA/AP]) chest radiograph view position
  • Missing CT report or final clinical diagnosis

结局指标

主要结局

Positive predictive value (PPV) of AI-detected interstitial opacity

时间窗: From the index chest radiograph to the reference standard confirmation (the first follow-up CT after the index chest radiograph and/or final clinical diagnosis), up to 3.5 years

Positive predictive value (PPV) of the AI flag for interstitial opacity is the proportion of AI interstitial-opacity-positive index radiographs confirmed as true positives by the radiologist reference standard (consensus review of the paired follow-up CT, CT report, follow-up diagnoses, and the index radiograph). PPV = true positives / all AI interstitial-opacity-positive cases.

次要结局

  • Comparison of AI finding scores between true-positive and false-positive cases(From the index chest radiograph to the reference standard confirmation (the first follow-up CT after the index chest radiograph and/or final clinical diagnosis), up to 3.5 years)

研究者

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

Kyoungmin Moon

Associate Professor of Pulmonary and Allergy Medicine

Chung-Ang University Hospital

研究点 (1)

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