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NOT YET RECRUITING
NCT06531343
NA

Advancing Lung Cancer Screening: Artificial Intelligence, Multimodal Imaging and Cutting-Edge Technologies for Early Detection and Characterization

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

Summary

Currently available screening programmes for lung cancer are limited by many challenges including low diagnostic accuracy, radiation exposure and high costs. New technologies in PET/CT scanners can allow cheaper and more sensitive exams with low radiation exposure. AI can be used to denoise LDCT to enhance the accuracy of imaging tests and build riskassessment models. This project aims to develop a new approach exploiting both these revolutionary advancements to bridge the existing gap in lung cancer screening. Patients in a high-risk population will be enrolled into two different cohorts undergoing LDCT scan and simultaneous \[18F\]FDG PET/CT on new-generation long axial field of view scanner (UO1) or screening with low LDCT only (UO2). AI will assist in image enhancement and interpretation and will develop a personalised risk-model guiding the following steps of clinical management, significantly improving early diagnosis of lung cancer, reducing mortality and healthcare costs.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

334

Start Date

2024-10-30

Completion Date

2026-08-30

Last Updated

2024-10-21

Healthy Volunteers

No

Interventions

PROCEDURE

LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner

18F\]FDG will be injected intravenously, and PET/CT images will be acquired after 60 minutes (± 10 minutes). PET/CT images will be first analysed with the lung window to detect any findings suggestive of a lung tumour. Whole-body PET/CT images will be then analysed to detect any incidental finding in the chest as well as other anatomical areas included in the field of view. PET/CT images will be considered positive if there is at least one non-calcified lung nodule or any suspicious finding on CT scan characterised by focal \[18F\]FDG uptake deviating from physiological distribution or above physiological background activity.

PROCEDURE

LDTC only

The LDCT scan will be performed in single deep inspiratory breath hold. No intravenous contrast will be administered.

Locations (1)

Irccs San Raffaele

Milan, Italy