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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: AI-assisted Low-Dose CT Interpretation

Detailed Description

Lung cancer is a leading cause of cancer-related mortality worldwide, and early detection is essential for improving survival. Low-dose computed tomography (LDCT) has been shown to reduce lung cancer mortality in high-risk populations, but image interpretation is time-consuming and may lead to overdiagnosis. Artificial intelligence (AI)-assisted diagnostic tools offer the potential to improve accuracy and efficiency in LDCT-based lung cancer screening, though challenges related to model adaptability, data heterogeneity, user trust, and regulatory compliance remain.

This multicenter pragmatic randomized controlled trial evaluates the effectiveness of AI-assisted LDCT interpretation compared with standard interpretation. Eligible participants will be randomized to an AI-assisted arm or a standard-reading arm. Outcomes include diagnostic accuracy, efficiency, lung cancer incidence, lung cancer mortality, recurrence, and smoking cessation.

The findings will provide evidence on the clinical utility of AI-assisted LDCT screening and support future implementation in routine practice and policy development.

• Study Type: Interventional
• Enrollment (Estimated): 1120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hao-Min Cheng, M.D., Ph.D; Phone Number: +886-2-28712121 ext 85322; Email: hmcheng@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taiwan
    • Taipei, Taiwan, Taiwan, 112
      • Taipei Veterans General Hospital
      • Contact: Hao-Min Cheng, M.D., Ph.D.; Phone Number: +886-2-28712121 ext 85322; Email: hmcheng@vghtpe.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-assisted LDCT Interpretation	Diagnostic test: AI-assisted Low-Dose CT Interpretation; Participants undergo low-dose computed tomography (LDCT) lung cancer screening. The images are first interpreted by AI-assisted software, which highlights suspicious nodules. Radiologists then review the AI outputs and generate the final report.
No Intervention: Standard Radiologist LDCT Interpretation; Participants undergo low-dose computed tomography (LDCT) lung cancer screening. Images are interpreted solely by radiologists without AI assistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Cancer Incidence	The proportion of newly diagnosed lung cancer cases identified within the specified follow-up period among all individuals who underwent LDCT screening.	From baseline to 12 months, 36 months, and 60 months.
False Positive Rate	The proportion of LDCT screening results interpreted as positive that are subsequently confirmed as non-lung cancer based on further diagnostic imaging or pathological examination.	Within 6 months following LDCT screening.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Cancer Mortality	The proportion of participants who die from lung cancer within the specified follow-up period after undergoing LDCT screening.	From baseline to 12 months, 36 months, and 60 months.
Lung Cancer Recurrence Rate	The proportion of patients previously diagnosed and treated for lung cancer who experience disease recurrence during the follow-up period.	From baseline to 12 months, 36 months, and 60 months.
All-Cause Mortality	The proportion of deaths from any cause among all individuals who underwent LDCT screening during the study period.	From baseline to 12 months, 36 months, and 60 months.
Time to Diagnosis	The time interval from LDCT screening to the date of confirmed lung cancer diagnosis, reported at the 12-month, 36-month, and 60-month follow-up time points.	At the 12-month, 36-month, and 60-month follow-up assessments after LDCT screening.
Time to Treatment Initiation	The time interval from the date of confirmed lung cancer diagnosis to the initiation of treatment, reported at the 12-month, 36-month, and 60-month follow-up time points.	At the 12-month, 36-month, and 60-month follow-up assessments after lung cancer diagnosis.
Follow-up Completion Rate	The proportion of individuals who completed the scheduled follow-up examinations or clinical evaluations within the designated follow-up period after undergoing LDCT screening.	Up to 12 months post-screening.
Smoking Cessation Rate	The proportion of individuals who successfully quit smoking within the follow-up period after LDCT screening	Assessed at 3 months, 6 months, and 12 months after baseline screening.

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: Far Eastern Memorial Hospital; Ministry of Health and Welfare, Taiwan; Taipei Municipal Guandu Hospital; Da Chien General Hospital; Kinmen Hospital, Ministry of Health and Welfare

Study record dates

Study Major Dates

• Study Start (Estimated): December 11, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2025-11-002AU-3AI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No