Clinical trial · Interventional
Advancing Lung Cancer Screening: Artificial Intelligence, Multimodal Imaging and Cutting-Edge Technologies for Early Detection and Characterization
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Screening | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner | Procedure | — | UNRESOLVED |
| LDTC only | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner
- interventionNames
- Procedure: LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner
- type
- ACTIVE_COMPARATOR
- label
- low LDCT only
- interventionNames
- Procedure: LDTC only
Primary outcomes (1)
- measure
- 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:
- timeFrame
- 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available