Radiomics for prEdiction of lunG cAncer biologY

Sponsor
Poitiers University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05819905
Collaborator
(none)
600
1
12
50

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PET/CT

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Prediction of Lung Cancer Characteristics Using PET/CT Radiomics
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Histologically proven NSCLCC

  • pre treatment 18F FDG PET/CT

  • available molecular biology and histology results

Exclusion Criteria:
  • non available PET/CT images

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Poitiers Poitiers France 86000

Sponsors and Collaborators

  • Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT05819905
Other Study ID Numbers:
  • REGAL
First Posted:
Apr 19, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2023