NCT07280559

Brief 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
1,120

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
69mo left

Started Dec 2025

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

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 Progress7%
Dec 2025Dec 2031

First Submitted

Initial submission to the registry

November 26, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

December 11, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

November 26, 2025

Last Update Submit

December 9, 2025

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Lung Cancer Mortality

    From baseline to 12 months, 36 months, and 60 months.

  • Lung Cancer Recurrence Rate

    From baseline to 12 months, 36 months, and 60 months.

  • All-Cause Mortality

    From baseline to 12 months, 36 months, and 60 months.

  • Time to Diagnosis

    At the 12-month, 36-month, and 60-month follow-up assessments after LDCT screening.

  • Time to Treatment Initiation

    At the 12-month, 36-month, and 60-month follow-up assessments after lung cancer diagnosis.

  • +2 more secondary outcomes

Study Arms (2)

AI-assisted LDCT Interpretation

EXPERIMENTAL
Diagnostic Test: AI-assisted Low-Dose CT Interpretation

Standard Radiologist LDCT Interpretation

NO INTERVENTION

Participants undergo low-dose computed tomography (LDCT) lung cancer screening. Images are interpreted solely by radiologists without AI assistance.

Interventions

AI-assisted Low-Dose CT InterpretationDIAGNOSTIC_TEST

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.

AI-assisted LDCT Interpretation

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Heavy Smoking History: Ages 50-74 with ≥20 pack-years smoking history, currently smoking or quit \<15 years ago.
  • General Screening Participants: Adults aged 40 years or older attending routine health check-ups.

You may not qualify if:

  • Pregnant women.
  • Chest CT or other higher-radiation chest imaging within the past 12 months.
  • Individuals holding a major illness certificate for lung cancer.
  • Inability to undergo thoracic puncture or surgery.
  • Inability to hold breath or otherwise complete the scanning procedure.
  • Hemoptysis of unknown cause within the past month.
  • Chest X-ray within the past month showing suspicious lung lesions.
  • Unexplained weight loss \>6 kg within the past year.
  • History of lung cancer within the past three years.
  • Presence of other severe diseases with an expected life expectancy \<5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan, 112, Taiwan

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Hao-Min Cheng, M.D., Ph.D

CONTACT

+886-2-28712121 ext 85322hmcheng@vghtpe.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 12, 2025

Study Start

December 11, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2031

Last Updated

December 12, 2025

Record last verified: 2025-12

Locations

TW(1)