NCT06295497

Lung Cancer Screening in HIgh Risk nonsmokErs by Artificial inteLligence Device

A Prospective Study on Artificial Intelligence Guided Lung Cancer Screening for High-risk Never Smokers in Hong Kong

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Lung cancer screening is currently not recommended in non-smokers due to paucity of evidence. Emerging evidence suggests that first-degree family history is a strong risk factor for lung cancer in Asian non-smokers. In Asia, lack of resource is a major challenge in successful implementation of lung cancer screening. Artificial intelligence (AI) is a promising tool to overcome this resource. In this study, we aim to study the clinical utility and demonstrate the feasibility of using an AI assisted programme for lung cancer screening in Asian non-smokers with a positive family history. This is a single-arm non-randomized lung cancer screening study. 3000 non-smokers, age 50 to 75 year old, with a first-degree family history of lung cancer, will be enrolled. Participants will undergo low does computed tomography (LDCT) of thorax and blood taking at enrolment. LDCT films will be interpreted by AI softwares for presence of lung nodules. Participants with lung nodules will be further investigated and followed up according to the risk of malignancy. The primary endpoint is the prevalence of early-staged lung cancer detected by first-round LDCT thorax in this population.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Lung-SIGHT	* The LDCT images will be interpreted by an artificial intelligence-based programme (Lung-SIGHT) for lung nodules. * b. In phase I, AI will serve as a first reader to screen LDCT scans. LDCT with lung nodules \>=5mm will be marked as abnormal, sent for reporting by board-certified radiologists and followed up in lung nodule clinic if the presence of lung nodules is confirmed. * c. In phase II, LDCT with lung nodules \>=5mm detected by AI will be categorized into different groups depending on risk of lung nodules and followed up with LDCT according to the risk. Subjects with high-risk nodules will be sent for reporting by board-certified radiologists and followed up in lung nodule clinic if the presence of high-risk nodules is confirmed. * Subjects with negative LDCT determined by AI programme (AI-) will undergo LDCT thorax and blood taking two years later (T1). Participants with normal second-round LDCT as determined by AI (AI-) or radiologists (AI+ Rad-) do not require follow up.

Timeline

• Start date: 2024-07-18
• Primary completion: 2028-09-01
• Completion: 2028-12-01
• First posted: 2024-03-06
• Last updated: 2026-03-18

Locations

1 site across 1 country: Hong Kong