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Not yet recruitingNCT07870928Updated Oct 15, 2026

The Impact of Artificial Intelligence-Assisted X-ray Interpretation on Radiologists' Diagnostic Performance

An observational study in Pneumothorax, Intestinal Obstruction and Spondylolysis, sponsored by The Third Affiliated Hospital of Southern Medical University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by The Third Affiliated Hospital of Southern Medical University · Observational

Updated Oct 15, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.
Read the detailed description

This is a multi-reader multi-case (MRMC) crossover diagnostic accuracy study using retrospective, de-identified X-ray images. Ten radiologists read the same set of cases under two conditions - unassisted reading and AI-assisted reading - in random order (AB/BA sequence), with a four-week washout between stages. Each radiologist serves as their own control. No patients are prospectively enrolled, and no new imaging procedures are performed.

02

Conditions studied

  • Pneumothorax
  • Intestinal Obstruction
  • Spondylolysis
  • Renal Calculus
03

In context

Pneumothorax

179 studies on the registry are indexed under Pneumothorax; 42 are open to participants now.

This study's planned enrollment of 500 is above the median of 122 across 59 observational studies indexed under Pneumothorax.

Browse Pneumothorax studies →

Lead sponsor

The Third Affiliated Hospital of Southern Medical University is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This study enrolls 10 radiologists from multiple hospitals as readers. They read retrospective, de-identified X-ray images of the chest, abdomen, and lumbar spine, collected from participating hospital image archives and public datasets. The image cases are from adult patients (age 18 years or older) with common X-ray findings across chest, abdominal, and spinal diseases. No patients are prospectively enrolled; all images are reused from routine clinical care after de-identification.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Unassisted Reading

    Radiologists read X-ray images using their usual clinical workflow, without access to any AI tool output. They record their diagnosis, confidence level, and reading time.

  • AI-Assisted Reading

    Radiologists read the same X-ray images while having access to the output of an X-ray imaging AI tool, including its diagnostic suggestions and predicted probabilities. The radiologist reviews the AI output and makes the final diagnosis, then records confidence level and reading time.

06

What researchers measure

Primary outcomes

  1. Macro-averaged Diagnostic Accuracy of Radiologists' Single-Disease Binary Detection (Balanced Accuracy)

    Diagnostic performance of radiologists on single-disease binary detection tasks for four common X-ray diseases. Accuracy is quantified as macro-averaged balanced accuracy (B-ACC) across the four diseases, comparing unaided reading versus AI-assisted reading. Each binary decision is compared against an expert-adjudicated reference standard established from clinical, imaging, and follow-up information.

    Time frame: Baseline (Stage 1 reading) and Week 4 (Stage 2 reading, after a 4-week washout period)

Secondary outcomes

  1. Per-disease Sensitivity and Specificity

    Disease-specific sensitivity and specificity of radiologists' binary diagnostic decisions under unaided versus AI-assisted conditions, estimated using generalized linear mixed-effects models.

    Time frame: Baseline (Stage 1 reading) and Week 4 (Stage 2 reading, after a 4-week washout period)

  2. Single-Disease Diagnostic Reading Time

    Time in seconds from case presentation to submission of the binary diagnostic decision, recorded by an independent timer per case. Compared between unaided and AI-assisted reading conditions.

    Time frame: Baseline (Stage 1 reading) and Week 4 (Stage 2 reading, after a 4-week washout period)

  3. Inter-Reader Diagnostic Agreement (Kappa)

    Inter-reader consistency of binary diagnostic decisions among the 10 participating radiologists, assessed by Kappa statistics, under unaided versus AI-assisted conditions.

    Time frame: Baseline (Stage 1 reading) and Week 4 (Stage 2 reading, after a 4-week washout period)

  4. Rate of Diagnostic Decision Changes With AI Assistance

    Proportion of cases for which each radiologist's binary decision differed between the unaided session and the AI-assisted session, classified as correct-to-incorrect or incorrect-to-correct changes.

    Time frame: Baseline (Stage 1 reading) and Week 4 (Stage 2 reading, after a 4-week washout period)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Also revised
primary outcomes
Registered
First appeared on the registry
Oct 13, 2026
Show all 2 updates
  1. Oct 15, 2026
    Primary outcomes Revised (2 changes)
    + 3 other changes: index terms, conditions and secondary outcomes
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07870928
Lead sponsor
The Third Affiliated Hospital of Southern Medical University
Responsible party
Junyan Li (Scientific Research Administrator, The Third Affiliated Hospital of Southern Medical University) — Principal investigator
First posted
Oct 13, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

HUANG WeiHong HUANG
Contact
13682232823@163.com
+86-13682232823

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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