NCT05704920

Integrating Artificial Intelligence Into Lung Cancer Screening.

A Randomized Controlled Study of Including a Deep Learning-based Analysis of Chest Computed Tomography as an Aid to Decision Making of Multidisciplinary Team Meetings for Lung Cancer Screening in Eligible Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,722 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Lung cancer (LC) screening using low-dose chest CT (LDCT) has already proven its efficacy. The mortality reduction associated with LC screening is around 20%, much higher than the reduction in mortality associated with screening for breast, colon or prostate cancers. Implementing lung cancer screening on a large scale faces two main obstacles: 1. The lack of thoracic radiologists and LDCT necessary for the eligible population (between 1.6 and 2.2 million people in France); 2. The high frequency of false positive screenings: in the NLST trial, more than 20% of the subjects screened were found to have at least one nodule of an indeterminate lung nodule (ILN) whereas less than 3% of ILNs are actually LC. The gold standard for determining on the benign or malignant nature of a nodule is definitive histology. Otherwise, the evolution of the nodule on serial thoracic imaging is a good alternative. The period of indeterminacy of a nodule can be as long as 24 months in many cases, which can be a source of prolonged and sometimes unjustified anxiety for screening candidates. The purpose of this randomized controlled study that focuses on LC screening in patients aged 50 to 80 years, who smoked more than 20 packs/ year or stopped smoking less than 15 years ago. Its objective is to determine whether assisting multidisciplinary team (MDT) meetings with an AI-based analysis of screening LDCT accelerates the definitive classification of nodules into malignant or benign.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
OTHER	IA	The multidisciplinary team meeting discussion is informed of the AI-based analysis of their chest computed tomography
OTHER	Not IA	The multidisciplinary team meeting discussion is not informed of the AI-based analysis of their chest computed tomography

Timeline

• Start date: 2024-04-08
• Primary completion: 2029-03-01
• Completion: 2030-10-01
• First posted: 2023-01-30
• Last updated: 2024-04-12

Locations

1 site across 1 country: France