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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

Detailed Description

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.

Interventions

  • Device: Miso PET scan
    • 2 PET scans will be performed before surgery : the first one with F-Miso tracer and the second, 24 hours later, with FAZA tracer
  • Device: FAZA PET scan
    • 2 PET scans will be performed before surgery : the first one with FAZA tracer and the second, 24 hours later, with F-Miso tracer

Arms, Groups and Cohorts

  • Experimental: Miso
    • 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
  • Experimental: FAZA
    • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • overall survival
    • Time Frame: one year
    • time between inclusion and the death whatever the cause
  • disease-free survival
    • Time Frame: one year
    • time between inclusion and the progression or death

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Henri Becquerel
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pierre Vera, MD, PhD, Principal Investigator, Centre Henri Becquerel

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