Radiomics for prEdiction of lunG cAncer biologY

NCT05819905 | Unknown

• 1 other identifier: REGAL
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Prediction of KRAS alteration

  1 month

• Prediction of BRAF mutation

  1 month

• Prediction of ALK/ROS translocation

  1 month

Interventions

PET/CT DIAGNOSTIC_TEST

Pre treatment staging 18F-FDG PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histologically proven NSCLC with molecular biology analysis and initial staging PET/CT

You may qualify if:

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

You may not qualify if:

• non available PET/CT images

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 19, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

FR (1)