Artificial Intelligence in Lung Cancer Screening

Lung Cancer Screening Clinical Trial

— INAIL BRIC  

Official title:

Development of an Artificial Intelligence Model in Lung Cancer Screening for the Diagnosis of Lung Nodules and Risk Stratification in Subjects With Occupational and/or Smoking Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06444373
• Other study ID #: 116/INT/2022
• Status: Completed
• Start date: December 2, 2022
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Scientific Institute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Single-center, non-profit, observational, retrospective study of collection of clinical and amnestic data and images to create, implement and develop a pilot model of an integrated virtual platform.

Description:

The project we propose is a study whose objective was to develop an artificial intelligence program integrated into a web-based platform for the optimization of the performance of lung cancer screening for the diagnosis of lung nodules and risk stratification in subjects exposed to environmental carcinogens and/or cigarette smoke.

Inclusion criteria:

Age > 50; smokers for at least 20 pack-years (20 cigarillos a day for 20 years) or former heavy smokers if they quit less than 15 years ago; and/or previous professional exposure to asbestos; absence of lung cancer symptoms; who performed lung cancer screening after the year 2000 upon approval of the study by the relevant EC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 728
• Est. completion date: May 30, 2024
• Est. primary completion date: May 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age > 50 years;

• smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago;

• and/or previous professional exposure to asbestos;

• absence of lung cancer symptoms;

• who performed lung cancer screening after the year 2000 upon approval of the study by the relevant Etical Committee

Exclusion Criteria:

• Age < 50 years

• never smokers

• lung cancer symptoms

Related Conditions & MeSH terms

• Lung Cancer Screening
• Lung Neoplasms

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Scientific Institute	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Scientific Institute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AIM 1 Pilot deep learning model	Development and fine-tuning of a pilot deep learning model for automatic detection and diagnosis of screen-detected nodules for risk stratification in subjects with asbestos exposure as part of a lung cancer screening program in high-risk subjects for exposure to asbestos and smoking on retrospective data.	from enrollment to the end of treatment at 2 years
Secondary	AIM 2 Clinical database	Development of an integrated system between the clinical database and several existing imaging volumetric software and risk models for the creation of a pilot platform in order to optimize the organizational management of lung cancer screening.	from enrollment to the end of treatment at 2 years