Comparative Study of the Hypoxia Measured in FAZA and F-miso PET/CT Scan in Patients With Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso in patients with non-small cell lung cancer and correlate the results of PET scans with immunohistochemistry.

Detailed Description
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The aim of the study is to compare the biodistribution of the two tracers specific for hypoxia in patients with non-small cell lung cancer. Two PET scans will be performed with FAZA and F-Miso tracers. The time between these twi PET scans will be 24 hours. another 24 hours after the late PET scan, the surgery will be done and a piece of tumor will be collected. Piece of tumor will be analysed by immunohistochemistry for hypoxia markers. The results of immunohistochemistry will be correlated with the biodistribution of the two tracers.

Official Title
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Comparative Study of the Hypoxia Measured in FAZA and F-miso TEP/CT Scan in Patients With Non-small Cell Lung Cancer at the Time of Diagnosis : Correlation With Immunohistochemistry

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Device: Miso PET scan
* Device: FAZA PET scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female More than 18 years old Patient with non-small cell lung cancer (histologically proved) PS inferior or equal to 1 (good general state) Patient must have surgery for their non-small cell lung cancer Stage of tumor Superior or equal to 2a without metastasis Tumoral fixation with 18-FDG-PET superior to mediastinal background noise Written inform consent Exclusion Criteria: Histology other than primitive non-small cell lung cancer In situ form at the histological study Patient without evaluable target No fixation on the pretherapeutic FDG-PET scan PS Superior or equal to 2 neoplastic disease (less than 2 years or progressive) Pregnant woman or child-bearing Patient Under guardianship or curators

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Miso<br>In this arm two PET scans wiil be realized. The first one will be made with F-Miso tracer. 24 hours later the FAZA PET scan will be performed. 24 hours after the last PET scan the surgery will be realized. During this surgery a piece of tumor will be collected and analyse by immunohistochemistry for markers of hypoxia | Device: Miso PET scan<br>* 2 PET scans will be performed before surgery : the first one with F-Miso tracer and the second, 24 hours later, with FAZA tracer<br>|
| Experimental: FAZA<br>In this arm two PET scans wiil be realized. The first one will be made with FAZA tracer. 24 hours later the F-Miso PET scan will be performed. 24 hours after the last PET scan the surgery will be realized. During this surgery a piece of tumor will be collected and analyse by immunohistochemistry for markers of hypoxia | Device: FAZA PET scan<br>* 2 PET scans will be performed before surgery : the first one with FAZA tracer and the second, 24 hours later, with F-Miso tracer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of hypoxia with FAZA and F-Miso tracer | SUV max, SUV mean and SUV peak were calculated for FAZA PET and Fmiso PET and will be correlated with results of immunohistochemistry | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | time between inclusion and the death whatever the cause | one year | 
| disease-free survival | time between inclusion and the progression or death | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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F-Miso, PET scan, FAZA, hypoxia, lung cancer