Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531343
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Advancing Lung Cancer Screening Artificial Intelligence Multimodal Imaging and Cutting-Edge Technologies for Early Detection and Characterization
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Advancing Lung Cancer Screening Artificial Intelligence Multimodal Imaging and Cutting-Edge Technologies for Early Detection and Characterization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PETCT 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 18FFDG PETCT 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
Detailed Description:
Assessment of the potential added value of low dose 18FFDG PETCT in the early detection of lung cancer in the screening work-up of the high-risk population The target population cohort 1 for the multimodal screening programme will be identified at UO1 on the basis of the PLCOM2012 prediction risk model All patients enrolled in cohort 1 will undergo a LDCT and a simultaneous low dose 18FFDG PET scan Whole body 18FFDG PETCT will be performed according to EANM Guidelines for tumour imaging Briefly patients will be instructed to fast for 6 hours and to avoid strenuous physical activity for 48 hours prior to the PETCT scan Diabetic patients will be instructed to fast for 4 hours prior to the scan and will be instructed on the use of medications according to the institutions protocol Blood glucose levels will be checked 18FFDG will be injected intravenously and PETCT images will be acquired after 60 minutes 10 minutes A new generation long axial field of view PETCT scanner Omni Legend General Electric Healthcare Waukesha WI USA will be used for whole body imaging
The control population cohort 2 will be identified in UO2 on the basis of the PLCOM2012 prediction risk model as previously described for cohort 1 The LDCT scan will be performed in single deep inspiratory breath hold No intravenous contrast will be administered LDCT images will be assessed and interpreted by at least two experienced radiologists LDCT will be defined as positive if at least one non-calcified lung nodule 5 mm in any diameter is detected LDCT will be defined as negative if no clinically significant morphological alterations are detected Non-calcified nodules of 3-5mm detected by LDCT will be reported Lung-RADS criteria will be used to classify detected lung nodules Any other suspicious morphological alteration will be reported The number size characteristics and location of any lesion detected will be recorded for each LDCT scan Any abnormality suggestive of clinically significant conditions other than cancer will be also reported Sensitivity specificity and accuracy will be calculated by per-patient and per-lesion analysis
The control population cohort 2 will be identified in UO2 on the basis of the PLCOM2012 prediction risk model as previously described for cohort 1 The LDCT scan will be performed in single deep inspiratory breath hold No intravenous contrast will be administered LDCT images will be assessed and interpreted by at least two experienced radiologists LDCT will be defined as positive if at least one non-calcified lung nodule 5 mm in any diameter is detected LDCT will be defined as negative if no clinically significant morphological alterations are detected Non-calcified nodules of 3-5mm detected by LDCT will be reported Lung-RADS criteria will be used to classify detected lung nodules Any other suspicious morphological alteration will be reported The number size characteristics and location of any lesion detected will be recorded for each LDCT scan Any abnormality suggestive of clinically significant conditions other than cancer will be also reported Sensitivity specificity and accuracy will be calculated by per-patient and per-lesion analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None