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

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Device: Miso PET scan; Device: FAZA PET scan

• Registration Number: NCT02490696
• Lead Sponsor: Centre Henri Becquerel

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-06
• Study First Posted: 2015-07-07
• Primary Completion: 2018-12
• Study Completion: 2019-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Miso	Miso PET scan	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
FAZA	FAZA PET scan	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

Primary Outcome Measures

Name	Time	Method
Comparison of hypoxia with FAZA and F-Miso tracer	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 Outcome Measures

Name	Time	Method
disease-free survival	one year	time between inclusion and the progression or death
overall survival	one year	time between inclusion and the death whatever the cause

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France