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Evaluation of AI-assisted LDCT Screening in Lung Cancer

NCT07280559 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1120

Last updated 2025-12-12

No results posted yet for this study

Summary

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

Interventions

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.

Sponsors & Collaborators

  • Far Eastern Memorial Hospital

    collaborator OTHER

  • Taipei Municipal Guandu Hospital

    collaborator UNKNOWN

  • Da Chien General Hospital

    collaborator OTHER

  • Kinmen Hospital, Ministry of Health and Welfare

    collaborator UNKNOWN

  • Ministry of Health and Welfare, Taiwan

    collaborator OTHER_GOV

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-11
Primary Completion
2027-12-31
Completion
2031-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07280559 on ClinicalTrials.gov