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Trial Title: Lung Cancer Screening by Artificial Intelligence Device

NCT ID: NCT06295497

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Lung-SIGHT
Description: - The LDCT images will be interpreted by an artificial intelligence-based programme (Lung-SIGHT) for lung nodules. - LDCT with lung nodules ≥5mm detected by AI programme (AI+) will be sent for reporting by board-certified radiologists. - Participants with abnormal LDCT reported by radiologists (Rad+) will be followed up at designated clinic. Management of lung nodules will follow the guidelines below for two years. - Participants with negative LDCT determined by AI programme (AI-) will undergo LDCT thorax and blood taking two years later (T1). Patients with lung nodules detected by AI programme (AI+) will be sent for radiologist reporting and those with abnormal CT reported by radiologists (Rad+) will be followed up in lung nodule clinic as per standard of care. Patients with normal second-round LDCT as determined by AI (AI-) or radiologists (AI+ Rad-) do not require follow up.
Arm group label: Artificial intelligence-based programme (Lung-SIGHT)

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: Patients are eligible to be included in the study only if all of the following criteria apply: 1. Age 50-75 years old 2. Non-smoker (defined as less than 100 cigarettes in lifetime) 3. Having a first-degree family history of lung cancer 4. Physically fit for curative treatment if early-staged lung cancer is found 5. Able to provide written informed consent 6. Consent to follow up visits and follow up CT scan if indicated 7. Consent to blood taking for translational research Exclusion Criteria: Patients who meet any of the following exclusion criteria at screening are not eligible to be enrolled in this study: 1. History of malignancy 2. Smoking history (defined as more than 100 cigarettes in lifetime) 3. Clinical symptoms suspicious for lung cancer e.g. haemoptysis, chest pain, weight loss 4. Medical comorbidities that preclude curative treatment (surgery) for lung cancer, such as severe heart disease, acute or chronic respiratory failure, home oxygen therapy, bleeding disorder 5. Pregnant ladies or ladies planning for conception 6. History of tuberculosis or interstitial lung disease 7. Pneumonia requiring antibiotic treatment within the last 12 weeks 8. CT thorax or chest performed within 2 years (including LDCT or CT coronary angiogram) 9. Unable or unwilling to provide written informed consent

Gender: All

Minimum age: 50 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of Clinical Oncology, Prince of Wales Hospital

Address:
City: Hong Kong
Country: Hong Kong

Contact:
Last name: Molly SC LI, MBBS, MRCP

Phone: 3505 2166
Email: molly@clo.cuhk.edu.hk

Contact backup:
Last name: Candy TANG, PC

Phone: 2479 8366
Email: candytang@cuhk.edu.hk

Start date: December 1, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: Chinese University of Hong Kong
Agency class: Other

Source: Chinese University of Hong Kong

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06295497

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