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

NCT06531343 | Not Yet Recruiting DMC

• 1 other identifier: PNRR-MCNT2-2023-12377755
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The primary objective is to assess the diagnostic accuracy of low-dose [18F]FDG PET/CT for screening in high-risk individuals or lung cancer Time Frame:

  The primary endpoint is the detection rate of \[18F\]FDG PET/CT for suspicious lung nodules. The sensitivity, specificity and accuracy will be calculated by a per-patient and per-lesion analysis based on the clinico-radiological follow-up. PET/CT images will be considered positive if there is at least one non-calcified lung nodule or one suspicious finding on CT scan characterised by focal \[18F\]FDG uptake that deviates from the physiological distribution or is above the physiological background activity. If there are no areas of increased uptake compared to physiological background activity, PET/CT images are considered negative.

  24 months

Secondary Outcomes (1)

• Assessment of the diagnostic accuracy of LDCT alone for screening in high-risk individuals or lung cancer and accuracy of [18F]FDG PET/CT for the additional detection of non-lung cancers in a high-risk population.

  24 months

Study Arms (2)

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

EXPERIMENTAL

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

low LDCT only

ACTIVE COMPARATOR

Procedure: LDTC only

Interventions

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

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.

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

LDTC only PROCEDURE

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

low LDCT only

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Blood glucose levels \>200 mg/dl,
• Ongoing pregnancy and breastfeeding
• Unwillingness to participate,
• Previous diagnosis of lung cancer,
• Previous CT scan within the last 24 months
• Concomitant severe clinical conditions and any condition that preclude the feasibility of the study

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Fondazione Policlinico Universitario Campus Bio-Medico: collaborator
• University of Calabria: collaborator
• University of Salerno: collaborator

Study Sites (1)

Irccs San Raffaele

Milan, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 1, 2024
• Study Start: October 30, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-07

Locations

IT (1)