Comparative Study of the Hypoxia Measured in FAZA and F-miso PET/CT Scan in Patients With Non-small Cell Lung Cancer (RTEP6)

Centre Henri Becquerel

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Device: Miso PET scan; Device: FAZA PET scan

Study type: Interventional

Funder types: Other

Identifiers

NCT02490696

CHB14.01

Details and patient eligibility

About

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 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

23 participants in 2 patient groups

Miso

Experimental group

Description:

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

Treatment:

Device: Miso PET scan

FAZA

Experimental group

Description:

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

Treatment:

Device: FAZA PET scan