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Status unknownNCT05819905Updated Apr 19, 2023

Radiomics for prEdiction of lunG cAncer biologY

An observational study in Non Small Cell Lung Cancer, PET/CT and PD-L1, sponsored by Poitiers University Hospital. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-19.

Sponsored by Poitiers University Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
600
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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

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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 600 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • non available PET/CT images
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
600 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testPET/CT

    Pre treatment staging 18F-FDG PET/CT

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month

  2. 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.

    Time frame: 1 month

Secondary outcomes

  1. 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.

    Time frame: 1 month

  2. 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.

    Time frame: 1 month

  3. 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.

    Time frame: 1 month

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Study locations

1 site
  • CHU Poitiers
    Poitiers, 86000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05819905
Lead sponsor
Poitiers University Hospital
Responsible party
Sponsor
First posted
Apr 19, 2023
Start date
Jan 1, 2023
Primary completion
Jan 1, 2024 (estimated)
Completion
Jan 1, 2024 (estimated)
Last update
Apr 19, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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