Lung Cancer Screening in High Risk NonsmokErs by Artificial InteLligence Device

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 1000 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: f
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⁃ Patients are eligible to be included in the study only if all of the following criteria apply:

• Age 50-75 years old

• Non-smoker (defined as less than 100 cigarettes in lifetime)

• Having a first-degree family history of lung cancer

• Physically fit for curative treatment if early-staged lung cancer is found

• Able to provide written informed consent

• Consent to follow up visits and follow up CT scan if indicated

• Consent to blood taking for translational research

Locations
Other Locations
Hong Kong Special Administrative Region
Department of Clinical Oncology, Prince of Wales Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Molly SC LI, MBBS, MRCP
molly@clo.cuhk.edu.hk
3505 2166
Backup
Candy TANG, PC
candytang@cuhk.edu.hk
2479 8366
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 1000
Treatments
Other: Artificial intelligence-based programme (Lung-SIGHT)
Artificial intelligence (AI) algorithms have been demonstrated to function well and complement radiologists as second or concurrent readers in pulmonary nodule detection. AI Lung nodule detection and quantification solution are now widely used in the hospitals in the United Kingdom and at least eight other European countries. The sensitivity of nodule detection by radiologists increased from 72% to 80% with the aid of the AI programme. A clinical trial in Taiwan showed that using AI programme alone achieved an overall sensitivity of 95.6% in nodule detection, and superior performance in detecting nodule sized 4-5 mm comparing to radiologists. Overall, application of AI in CT analysis and lung nodule detection may significantly reduce the cost and workload of radiologist.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov