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NCT07280559Not yet recruiting

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 · Last updated 12 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
1120 (estimated)
First submitted
26 Nov 2025
Start date
11 Dec 2025
Primary completion date
31 Dec 2027
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Diseases
Lung cancer
NCT number
NCT07280559

What you commit to

  • Study type: Interventional
  • Planned participants: 1120
  • From 11 Dec 2025 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Chest CT or other higher-radiation chest imaging within the past 12 months.
  • Inability to undergo thoracic puncture or surgery.

Other illness

  • Individuals holding a major illness certificate for lung cancer.
  • History of lung cancer within the past three years.

Age

  • Presence of other severe diseases with an expected life expectancy \<5 years.

Other

  • Pregnant women.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 40 years to 74 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Taipei Veterans General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.