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NCT07870928
The Impact of Artificial Intelligence-Assisted X-ray Interpretation on Radiologists' Diagnostic Performance
Conditions: Pneumothorax, Intestinal Obstruction, Spondylolysis, Renal Calculus
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 500
Sponsor: The Third Affiliated Hospital of Southern Medical University
Summary
This study tests whether an artificial intelligence (AI) tool helps radiologists read X-rays more accurately.
Radiologists read X-rays to find diseases such as pneumonia, bone fractures, and abdominal problems. AI is a computer program trained on many past X-rays. It may help radiologists spot diseases faster and more correctly. This study compares reading X-rays with the AI tool to reading X-rays without it.
Who takes part
* Ten radiologists from several hospitals.
* X-ray images from about 300 to 500 past hospital visits.
* No new X-rays are taken.
* All names and ID numbers are removed from the images.
What happens
* Each radiologist reads the same set of X-rays twice.
* One time, the radiologist reads without the AI tool.
* The other time, the radiologist can see the AI result.
* Half start with no AI and then switch to AI. The other half start with AI and then switch to no AI.
* There is a four-week break between the two times.
* The researchers measure how accurate each radiologist is. They also time how long each image takes.
Possible benefits and risks
* The radiologists may get no direct personal benefit.
* The results may show whether AI can help doctors read X-rays better in the future.
* This is a low-risk study. The AI tool never tells a patient a diagnosis directly.
* A qualified radiologist always makes the final diagnosis.
* Patient data is stored on a locked, encrypted server.
Eligibility Criteria
Inclusion Criteria:
* Participants (radiologists): actively practicing radiologists at participating hospitals, stratified by hospital and professional seniority, trained for the study reading task, and willing to provide written informed consent.
* Cases (X-ray images): adult patients aged 18 years or older who underwent X-ray imaging of the chest, abdomen, or lumbar spine for clinical indications.
* Cases with complete basic clinical information.
* Cases with an established gold-standard diagnosis, defined as the comprehensive clinical diagnosis or a consensus opinion from at least two senior radiologists (deputy chief physician or above).
Exclusion Criteria:
* Cases with poor image quality that prevents reliable interpretation.
* Cases without a clear gold-standard diagnosis or with missing key clinical information.
* Duplicate cases.
* Cases in which the patient recently received radiotherapy, chemotherapy, or other treatment that would significantly alter imaging appearance and confound diagnosis.
* Cases judged by the investigators as unsuitable for the study for any other reason.
* Radiologists: no additional exclusion criteria beyond the inclusion requirements.
Source: ClinicalTrials.gov (NCT07870928). StuddyBuddy aggregates publicly available trial information.