NCT05195385

Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,635 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 50 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether reading of low-dose thoracic CT scans can be done by a single general radiologist who has been trained to lung cancer screening, and will evaluate the performance in comparison with double reading by experts. The study will enroll women between 50 and 74 years old, at risk for lung cancer due to their smoking history.

Detailed description

Lung cancer is the leading cause of cancer death, worldwide. Several randomized studies have demonstrated that annual or biennial low-dose CT screening reduces lung cancer mortality. However, these studies involved expert chest radiologists, with double reading being performed in most studies. Furthermore, none of the published studies have evaluated the role of artificial intelligence to serve as second of concurrent reader. Women with at least 20 pack-year smoking history who quitted smoking less than 15 years ago will be enrolled to have baseline, 1-year and 2-year low-dose CT of the chest. The CT scans will be read on site by a general radiologist trained to lung cancer screening according to the European lung cancer screening certification program, first without then with the aid of an artificial algorithm trained to lung nodule detection (Veye Chest, Aidence). All CT scans will also be read by 2 chest experts, who will resolve their disagreement by a consensus reading if necessary. Patient management will rely on the double reading by expert. The criteria for positive screen result are as follows: solid nodule \> 500 mm3 (10 mm) or growing (30% volume increase), part-solid nodule with \> 8 mm solid component or new or growing, pure ground glass nodule developing a solid portion.

Conditions

• Lung Cancer Screening

Interventions

Type	Name	Description
PROCEDURE	Low-dose computed tomography of the chest	Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules

Timeline

• Start date: 2022-04-08
• Primary completion: 2027-10-08
• Completion: 2027-10-08
• First posted: 2022-01-19
• Last updated: 2026-03-30

Locations

1 site across 1 country: France