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

NCT06531343 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2024-10-21

No results posted yet for this study

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.

Conditions

  • Lung Cancer Screening

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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Campus Bio-Medico

    collaborator OTHER

  • University of Calabria

    collaborator OTHER

  • University of Salerno

    collaborator OTHER

  • IRCCS San Raffaele

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2026-03-01
Completion
2026-08-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06531343 on ClinicalTrials.gov