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Completed

NCT Number: NCT02490696

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Hypoxia Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Signs and Symptoms, Respiratory Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Henri Becquerel

Rouen, 76000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Miso PET scan

Device

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

FAZA PET scan

Device

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

Primary outcomes

  1. 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 outcomes

  1. overall survival

    Time frame: one year

    time between inclusion and the death whatever the cause

  2. disease-free survival

    Time frame: one year

    time between inclusion and the progression or death

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: RTEP6

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jul 7, 2015
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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