Clinical trial · Observational
Assessing AI for Detecting Lung Nodules and Cancer: Pre- and Post-Deployment Study
An Ambispective Pre and Post Deployment Observational Cohort Study to Evaluate the Yield of Actionable Lung Nodules and Lung Cancer Through Chest X-Rays Using Artificial Intelligence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No IRB approval
Summary
Brief summary (as posted)
The study evaluates the impact of qXR-LN compared to standard radiologist-only interpretations before and after AI deployment. The goal is to compare how well lung nodules and cancers are detected in two time periods: before and after the implementation of the AI tool in routine clinical practice. The study aims to determine whether the AI system can help radiologists identify more actionable lung nodules and diagnose lung cancer earlier, ultimately improving patient outcomes. No changes will be made to patients' standard care, and all treatment decisions will be based on the clinical judgment of physicians. The study includes patients over 35 years old who undergo chest X-rays for various medical reasons, excluding those with known lung cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence in Radiology | — | UNRESOLVED | — |
| Computer-Aided Detection | — | UNRESOLVED | — |
| Early-Stage Lung Cancer | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Lung Cancers | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Nodules | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Pre-Deployment Cohort
- description
- Patients undergoing standard chest X-rays prior to the introduction of the AI-based Computer Aided Detection (CAD) system. This cohort represents the baseline population used for comparison, with no AI intervention applied during their imaging or reporting process.
- label
- Post-Deployment Cohort
- description
- Patients undergoing chest X-rays after the AI-based Computer Aided Detection (CAD) tool has been integrated into the clinical workflow. Although not assigned as an "intervention group" per a traditional trial protocol, these patients receive imaging evaluated by the AI tool, and the impact on diagnostic outcomes will be compared to the pre-deployment cohort.
Primary outcomes (1)
- measure
- Difference in Nodule Detection Rate Between Pre- and Post-Deployment Cohorts
- timeFrame
- Through study completion, approximately 12 months.
- description
- Compare the proportion of patients with lung nodules detected on chest X-rays before and after implementing the AI tool (qXR-LN). Lung nodule detection will be determined by radiological interpretation of chest X-rays. For the pre-deployment cohort, the presence or absence of nodules will be derived from radiology reports and confirmed by a clinical research associate. For the post-deployment cohort, nodules identified by qXR-LN and subsequently reviewed by radiologists (using the qTrack tool) will serve as the primary measure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥35 years at the time of chest X-ray acquisition * Chest X-ray must be obtained as part of routine care (e.g., ordered for respiratory complaints, screening, or other clinical indications) * Chest X-ray performed using CR/DR/DX imaging modality * Examination described as "Chest" * View: PA or AP * Patient positioned as Erect or Supine * Image available in valid DICOM format with proper DICOM prefix values (including "DICM" in the header) Exclusion Criteria: * Patients aged \<35 years at the time of chest X-ray * Patients with known lung cancer at the time of chest X-ray acquisition * Lateral views or any imaging modality other than CR/DR/DX * Imaging or anatomy not specified as Chest (e.g., different body parts or modalities)
References
Publications (0)
Data not yet available