Clinical trial · Interventional
Evaluation of AI-assisted LDCT Screening in Lung Cancer
Evaluation of AI Medical Software-assisted LDCT Interpretation in Lung Cancer Screening and Prognosis: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicenter pragmatic randomized controlled trial evaluates whether AI-assisted interpretation of low-dose CT (LDCT) improves lung cancer screening performance compared with standard reading. Eligible participants are randomized to AI-assisted or conventional interpretation. The study assesses diagnostic accuracy, efficiency, lung cancer incidence, mortality, recurrence, and smoking cessation outcomes. Results will inform the clinical utility and potential implementation of AI-assisted LDCT in routine screening practice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-assisted Low-Dose CT Interpretation | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AI-assisted LDCT Interpretation
- interventionNames
- Diagnostic Test: AI-assisted Low-Dose CT Interpretation
- type
- NO_INTERVENTION
- label
- Standard Radiologist LDCT Interpretation
- description
- Participants undergo low-dose computed tomography (LDCT) lung cancer screening. Images are interpreted solely by radiologists without AI assistance.
Primary outcomes (2)
- measure
- Lung Cancer Incidence
- timeFrame
- From baseline to 12 months, 36 months, and 60 months.
- description
- The proportion of newly diagnosed lung cancer cases identified within the specified follow-up period among all individuals who underwent LDCT screening.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: 1. Family History of Lung Cancer: Males aged 45-74 or females aged 40-74 with first-degree relatives (parents, siblings, or children) diagnosed with lung cancer. 2. Heavy Smoking History: Ages 50-74 with ≥20 pack-years smoking history, currently smoking or quit \<15 years ago. 3. General Screening Participants: Adults aged 40 years or older attending routine health check-ups. Exclusion Criteria: 1. Pregnant women. 2. Chest CT or other higher-radiation chest imaging within the past 12 months. 3. Individuals holding a major illness certificate for lung cancer. 4. Inability to undergo thoracic puncture or surgery. 5. Inability to hold breath or otherwise complete the scanning procedure. 6. Hemoptysis of unknown cause within the past month. 7. Chest X-ray within the past month showing suspicious lung lesions. 8. Unexplained weight loss \>6 kg within the past year. 9. History of lung cancer within the past three years. 10. Presence of other severe diseases with an expected life expectancy \<5 years.
References
Publications (0)
Data not yet available