Radiomics for prEdiction of lunG cAncer biologY

Active, not recruiting

• Conditions: Non Small Cell Lung Cancer; PD-L1; PET/CT; Gene Mutation-Related Cancer

• Registration Number: NCT05819905
• Lead Sponsor: Poitiers University Hospital

Brief Summary

Therapeutic progress for subgroups of Non Small Cell Lung Cancer can largely be attributed to the accumulation of molecular knowledge and the development of new drugs that specifically target molecular abnormalities. An understanding of the immune landscape of tumors, including immune-evasion strategies, has also led to breakthrough therapeutic advances.These new options require prior treatment tumoral sampling to identify patients who have neoplasms with specific genomic aberrations or favorable immune environment. Medical imaging and radiomic approach may provides surrogate markers non invasively.The objective of the present retrospective study is to build and validate a predictive model of common molecular alterations and PD-L1 expression in NSCLC using pre treatment PET/CT derived radiomics.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-03-17
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-05
• Last Update Submitted: 2023-04-05
• Study First Posted: 2023-04-19
• Last Update Posted: 2023-04-19
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Histologically proven NSCLCC
• pre treatment 18F FDG PET/CT
• available molecular biology and histology results

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Exclusion Criteria

• non available PET/CT images

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prediction of PDL1 expression	1 month	Evaluation of the performances of PET/CT derived radiomics to predict PDL1 expression \>1% (PDL1 : Programmed death-ligand 1 as previously determined on routine tumoral biopsy): area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity.
prediction of EGFR genomic alteration	1 month	Evaluation of the performances of PET/CT derived radiomics to predict the presence of EGFR mutation (EGFR: epidermal growth factor receptor, presence /or not of EGFR alteration as previously determined on routine tumoral biopsy): area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity.

Secondary Outcome Measures

Name	Time	Method
Prediction of KRAS alteration	1 month	Evaluation of the performances of PET/CT derived radiomics to predict the presence of KRAS mutation (KRAS : Kirsten rat sarcoma viral oncogene : presence/or not of KRAS alteration as previously determined on routine tumoral biopsy): area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity.
Prediction of BRAF mutation	1 month	Evaluation of the performances of PET/CT derived radiomics to predict the presence of BRAF mutation (BRAF : raf murine sarcoma viral oncogene homolog B, presence/or not of BRAF mutation as previously determined on routine tumoral biopsy): area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity.
Prediction of ALK/ROS translocation	1 month	Evaluation of the performances of PET/CT derived radiomics to predict the presence of ALK/ROS translocation (ALK : anaplastic lymphoma receptor tyrosine kinase, ROS : c-ROS protooncogene 1; presence /or not of ALK and ROS alteration as previously determined on routine tumoral biopsy): area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity.

Trial Locations

Locations (1)

CHU Poitiers; 🇫🇷 Poitiers, France