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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

Qualifiers

Age > 50 years

PLCOm2012 risk prediction > 4%

Be willing to adhere to the study intervention through [18F]FDG PET/CT or LDCT imaging

Signed written informed consent form

Disqualifiers

Blood glucose levels >200 mg/dl,

Ongoing pregnancy and breastfeeding

Unwillingness to participate,

Previous diagnosis of lung cancer,

Trial design

Treatments tested in this trial

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

Treatment groups

334 Participants
are divided into 2 treatment groups

Sponsors and collaborators

IRCCS San Raffaele

Lead sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Collaborator

University of Calabria

Collaborator

University of Salerno

Collaborator