Radiomics for prEdiction of lunG cAncer biologY

Non Small Cell Lung Cancer Clinical Trial

Official title:

Prediction of Lung Cancer Characteristics Using PET/CT Radiomics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05819905
• Other study ID #: REGAL
• Status: Active, not recruiting
• Start date: January 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: April 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven NSCLCC

• pre treatment 18F FDG PET/CT

• available molecular biology and histology results

Exclusion Criteria:

• non available PET/CT images

Related Conditions & MeSH terms

• Gene Mutation-Related Cancer
• Lung Neoplasms
• Non Small Cell Lung Cancer
• PD-L1
• PET/CT

Intervention

Diagnostic Test:
• PET/CT
Pre treatment staging 18F-FDG PET/CT

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prediction of PDL1 expression	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.	1 month
Primary	prediction of EGFR genomic alteration	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.	1 month
Secondary	Prediction of KRAS alteration	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.	1 month
Secondary	Prediction of BRAF mutation	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.	1 month
Secondary	Prediction of ALK/ROS translocation	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.	1 month