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临床试验 NCT07497243 针对Chest X-ray for Clinical Evaluation目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
X-ray Assisted Diagnostic System 16,000
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临床试验NCT07497243是一项针对Chest X-ray for Clinical Evaluation的观察研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年5月1日开始，预计招募16,000名患者。该研究由Union Hospital, Tongji Medical College, Huazhong University of Science and Technology主导，计划于2026年11月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月27日。
简要概括
X-ray examination is one of the most commonly used imaging modalities, especially chest X-ray, which is routinely performed for hospitalized patients. However, due to the low density resolution of X-ray images, radiologists' ability to diagnose diseases-particularly small lesions-is often affected. Studies have shown that the diagnostic accuracy of radiologists using chest X-rays is only around 70%, which does not me...显示更多
官方标题
Construction and Clinical Application of an X-ray AI-Aided Diagnosis System: A Randomized Controlled Trial
疾病
Chest X-ray for Clinical Evaluation其他研究标识符
- X-Ray-001
NCT编号
实际开始日期
2026-05-01
最近更新发布
2026-03-27
预计完成日期
2026-11-30
计划入组人数
16,000
研究类型
观察研究
试验状态
尚未招募
关键词
X-Ray
AI
Chest diseases
Accuracy
AI
Chest diseases
Accuracy
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Radiologist diagnostic group After the patient undergoes an X-ray examination, a radiologist generates the report and makes the diagnosis. | Radiologist diagnostic group After the patient undergoes an X-ray examination, a radiologist generates the report and makes the diagnosis. |
AI-assisted radiologist diagnostic group After the patient undergoes an X-ray examination, an AI-assisted radiologist generates the report and makes the diagnosis. | AI-assisted radiologist diagnostic group Based on the previously developed X-ray image diagnosis and report generation model, radiologists are assisted in interpreting X-ray images and generating reports. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Area Under the Curve | The primary outcome was the AUC to evaluate diagnostic performance, comparing radiologists with and without AI assistance. | From enrollment to the end of X-ray image acquisition at 1 week |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
X-ray report generation time | X-ray report generation time refers to the amount of time required to produce a diagnostic report after an X-ray examination has been performed. It typically measures the interval from when the X-ray images are acquired to when the radiologist (with or without AI assistance) completes and finalizes the report. | From enrollment to the end of X-ray image acquisition at 1 week |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
适龄性别
全部
接受健康志愿者
是
- Clinically suspected thoracic diseases (such as pneumonia, tuberculosis, or lung cancer) requiring X-ray diagnosis；
- Patients providing written informed consent for research data use；
- Complete clinical records (including chief complaints, medical history, and laboratory test results)
- Substandard X-ray image quality (including severe motion artifacts, over-/underexposure, or missing anatomical structures)
- Pregnant or lactating women
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology研究中心联系人
联系人: Huangxuan Zhao, PhD, 18971676985, [email protected]
4 位于 1 个国家/地区的研究中心
Hubei
Wuhan Union Hospital, Wuhan, Hubei, 430022, China
Lei Chen, MD, 联系人, 15971480677, [email protected]
Wuhan Union Jinyin Lake Hospital, Wuhan, Hubei, 430022, China
Lei Chen, 联系人, 15971480677, [email protected]
Wuhan Union West Hospital, Wuhan, Hubei, 430022, China
Huangxuan Zhao, 联系人, 18971676985, [email protected]
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
Huangxuan Duan, 联系人, 13209867189, [email protected]