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Not yet recruiting NCT07497243

X-ray Assisted Diagnostic System

Observational Chest X-ray for Clinical Evaluation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-assisted radiologist diagnostic group, Radiologist diagnostic group.
Who it may be relevant to
Registry conditions: Chest X-ray for Clinical Evaluation. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 test 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.
  • Diagnostic test Radiologist diagnostic group
    After the patient undergoes an X-ray examination, a radiologist generates the report and makes the diagnosis.

Primary outcome measures

  • Area Under the Curve [Time frame: From enrollment to the end of X-ray image acquisition at 1 week]
Secondary outcome measures (1)
  • X-ray report generation time [Time frame: From enrollment to the end of X-ray image acquisition at 1 week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 4 centers
  • Wuhan Union Hospital — Wuhan
  • Wuhan Union Jinyin Lake Hospital — Wuhan
  • Wuhan Union West Hospital — Wuhan
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou

Identifiers

NCT: NCT07497243 · X-Ray-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗