NCT07834879

Brief Summary

Chest X-rays are widely used to detect thoracic and lung conditions, but reviewing high volumes of radiographs can lead to workload strain and variation between interpreters. Artificial intelligence (AI), particularly deep learning neural networks like DenseNet-121, has shown strong potential to assist clinicians with automated image interpretation. However, AI models trained on large international datasets, such as CheXpert, may perform differently across distinct patient populations due to variations in imaging technique, patient demographics, and disease presentation. The primary purpose of this study is to compare the diagnostic accuracy of a DenseNet-121 model trained or fine-tuned on local data against a DenseNet-121 model pretrained on the CheXpert dataset for identifying thoracic pathologies. Both models will evaluate de-identified frontal chest radiographs from adult patients. Model predictions will be compared against a reference standard established by expert radiologist consensus, with discordant findings resolved using chest computed tomography (CT). Findings will evaluate whether local model adaptation improves diagnostic precision and workflow efficiency in clinical settings.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

September 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 17, 2026

Last Update Submit

September 17, 2026

Conditions

Keywords

DenseNet-121CheXpertChest X-rayDeep LearningArtificial IntelligenceDiagnostic AccuracyConvolutional Neural Network

Outcome Measures

Primary Outcomes (1)

  • Area Under the Receiver Operating Characteristic Curve (AUROC)

    AUROC will be calculated to assess and compare the diagnostic performance of the study-trained DenseNet-121 model versus the CheXpert-pretrained DenseNet-121 model in detecting thoracic pathologies on frontal chest radiographs. AI predictions will be compared against the reference standard of expert radiologist consensus, with discordant findings adjudicated by chest CT. AUROC values range from 0.5 (no discrimination) to 1.0 (perfect discrimination).

    Baseline

Study Arms (1)

Adult Frontal Chest Radiography Cohort

This cohort includes adult patients aged 18 years and older who undergo diagnostic-quality frontal chest radiography with available reference diagnostic labels. De-identified chest radiographs from this group are evaluated by two deep learning architectures: a study-trained/fine-tuned DenseNet-121 convolutional neural network and a CheXpert-pretrained DenseNet-121 model. Model predictions are evaluated against reference standards derived from expert radiologist consensus, with discordant cases adjudicated via chest computed tomography (CT).

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population comprises adult patients aged 18 years and older who undergo frontal chest radiography within institutional radiology departments. Eligible subjects have de-identified, diagnostic-quality frontal chest X-ray images with available reference diagnostic labels verified through expert radiologist consensus and chest CT adjudication. Pediatric cases, non-diagnostic images, incomplete metadata, and duplicate scans are excluded.

You may qualify if:

  • Adult patients aged 18 years or older.
  • Undergoing frontal chest radiography.
  • Diagnostic-quality frontal chest radiographs.
  • Availability of reference diagnostic labels (verified by expert radiologist consensus or chest CT).

You may not qualify if:

  • Pediatric patients (under 18 years of age).
  • Non-diagnostic or poor-quality chest radiographs.
  • Incomplete clinical or imaging metadata.
  • Duplicate radiographic images or repeat patient entries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thoracic DiseasesLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 22, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 22, 2026

Record last verified: 2026-09