Lung Cancer Screening by Artificial Intelligence Device

Lung Cancer Clinical Trial

Official title:

Lung Cancer Screening in High Risk nonsmokErs by Artificial inteLligence Device

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06295497
• Other study ID #: LC-SHIELD
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: Molly SC LI, MBBS, MRCP
• Phone: 3505 2166
• Email: molly[@]clo.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• Lung-SIGHT
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.

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of early-staged lung cancer detected by first-round LDCT thorax (T0) in a high-risk non-smoker population		2 years
Secondary	Sensitivity of AI-assisted programme in lung nodule detection and monitoring compared to radiologist assessment		2 years
Secondary	Rate of invasive workup and incidence of associated complications.		2 years
Secondary	Prevalence of lung cancer detected by second-round LDCT (T1) in patients with negative first-round LDCT		2 years
Secondary	Diagnostic accuracy and discrimination ability of plasma-based fragmentomic assay in detection of lung cancer via assessment of sensitivity, specificity, positive predictive value and negative predictive value		2 years
Secondary	To determine the quality adjusted life years (QALYs) gained through screening		2 years