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X-ray Assisted Diagnostic System

Construction and Clinical Application of an X-ray AI-Aided Diagnosis System: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07497243
Enrollment
16000
Registered
2026-03-27
Start date
2026-05-01
Completion date
2026-11-30
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest X-ray for Clinical Evaluation

Keywords

X-Ray, AI, Chest diseases, Accuracy

Brief summary

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 meet clinical demands. Based on this, we developed an artificial intelligence model to assist radiologists in interpreting X-ray images and generating reports, with the aim of improving diagnostic accuracy and reducing interpretation time.

Interventions

DIAGNOSTIC_TESTAI-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.

DIAGNOSTIC_TESTRadiologist diagnostic group

After the patient undergoes an X-ray examination, a radiologist generates the report and makes the diagnosis.

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* Substandard X-ray image quality (including severe motion artifacts, over-/underexposure, or missing anatomical structures) * Pregnant or lactating women

Design outcomes

Primary

MeasureTime frameDescription
Area Under the CurveFrom enrollment to the end of X-ray image acquisition at 1 weekThe primary outcome was the AUC to evaluate diagnostic performance, comparing radiologists with and without AI assistance.

Secondary

MeasureTime frameDescription
X-ray report generation timeFrom enrollment to the end of X-ray image acquisition at 1 weekX-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.

Countries

China

Contacts

CONTACTHuangxuan Zhao, PhD
zhao_huangxuan@sina.com18971676985

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026