Lung CancerNCT07280559
Evaluation of AI-assisted LDCT Screening in Lung Cancer
A study testing AI-assisted Low-Dose CT Interpretation in people with Lung Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- AI-assisted Low-Dose CT Interpretation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,120 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Dec 2025to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Hao-Min Cheng, M.D., Ph.D., +886-2-28712121 ext 85322, hmcheng@vghtpe.gov.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- AI-assisted Low-Dose CT Interpretation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted LDCT Interpretation | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 6 months following LDCT screening.
Secondary outcomes (7)
Lung Cancer Mortality
The proportion of participants who die from lung cancer within the specified follow-up period after undergoing LDCT screening.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Assessed at 3 months, 6 months, and 12 months after baseline screening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start11 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Far Eastern Memorial Hospital, Taipei Municipal Guandu Hospital, Da Chien General Hospital, Kinmen Hospital, Ministry of Health and Welfare, Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280559
- Sponsor's protocol ID
- 2025-11-002AU-3AI
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of AI Medical Software-assisted LDCT Interpretation in Lung Cancer Screening and Prognosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07280559
- Acronym / sponsor ID
- 2025-11-002AU-3AI
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Far Eastern Memorial Hospital, Taipei Municipal Guandu Hospital, Da Chien General Hospital, Kinmen Hospital, Ministry of Health and Welfare, Ministry of Health and Welfare, Taiwan
- Study start
- 11 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-assisted Low-Dose CT InterpretationParticipants 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. | Diagnostic test | AI-assisted LDCT Interpretation |
Primary outcome
Lung Cancer Incidence
Time frame: From baseline to 12 months, 36 months, and 60 months.
The proportion of newly diagnosed lung cancer cases identified within the specified follow-up period among all individuals who underwent LDCT screening.
False Positive Rate
Time frame: Within 6 months following LDCT screening.
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.
7 secondary outcomes
Lung Cancer Mortality
Time frame: From baseline to 12 months, 36 months, and 60 months.
Lung Cancer Recurrence Rate
Time frame: From baseline to 12 months, 36 months, and 60 months.
All-Cause Mortality
Time frame: From baseline to 12 months, 36 months, and 60 months.
Time to Diagnosis
Time frame: At the 12-month, 36-month, and 60-month follow-up assessments after LDCT screening.
Time to Treatment Initiation
Time frame: At the 12-month, 36-month, and 60-month follow-up assessments after lung cancer diagnosis.
Follow-up Completion Rate
Time frame: Up to 12 months post-screening.
Smoking Cessation Rate
Time frame: Assessed at 3 months, 6 months, and 12 months after baseline screening.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted Low-Dose CT Interpretation in people with Lung Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao-Min Cheng, M.D., Ph.D (+886-2-28712121 ext 85322, hmcheng@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Cancer Incidence (time frame: From baseline to 12 months, 36 months, and 60 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.