Artificial Intelligence (AI) Detection of Incidental Interstitial Opacity on Chest Radiography
2026年7月5日 更新者：Kyoungmin Moon、Chung-Ang University Hospital
Evaluating the Real-World Performance of Artificial Intelligence (AI)-Based Detection for Interstitial Lung Disease in Chest X-Ray Images
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.
研究概览
研究类型
观察性的
注册 (实际的)
1293
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Seoul
-
Seoul、Seoul、韩国、06973
- Chung-Ang University Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
Adults aged ≥19 years attending the pulmonology and allergy clinics of Chung-Ang University Hospital (Seoul and Gwangmyeong, Republic of Korea) who underwent chest radiography between January 2022 and December 2024.
描述
Inclusion Criteria:
- 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™
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
AI interstitial opacity-positive
Patients whose index chest radiograph was flagged as interstitial opacity-positive by the AI software.
|
VUNO Med®-Chest X-ray™ is artificial intelligence (AI)-based software that supports the detection and diagnosis of abnormal findings on chest radiographs.
It automatically identifies abnormal findings and provides information on their type and location to aid clinical decision-making.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Positive predictive value (PPV) of AI-detected interstitial opacity
大体时间：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.
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Comparison of AI finding scores between true-positive and false-positive cases
大体时间：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
|
The AI finding scores (e.g., interstitial opacity, consolidation, nodule, pleural effusion) were compared between interstitial-opacity true-positive and false-positive cases using the Mann-Whitney U test.
Scores are summarized as the median (first-third quartile, Q1-Q3).
|
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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年2月1日
初级完成 (实际的)
2024年12月31日
研究完成 (实际的)
2024年12月31日
研究注册日期
首次提交
2026年6月25日
首先提交符合 QC 标准的
2026年7月5日
首次发布 (实际的)
2026年7月7日
研究记录更新
最后更新发布 (实际的)
2026年7月7日
上次提交的符合 QC 标准的更新
2026年7月5日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.