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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02490696
Acronym
RTEP6
Enrollment
23
Registered
2015-07-07
Start date
2015-06-01
Completion date
2019-10-31
Last updated
2020-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

PET scan, FAZA, F-Miso, hypoxia, lung cancer

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.

Interventions

DEVICEMiso 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

DEVICEFAZA 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

Sponsors

Centre Henri Becquerel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of hypoxia with FAZA and F-Miso tracerone yearSUV max, SUV mean and SUV peak were calculated for FAZA PET and Fmiso PET and will be correlated with results of immunohistochemistry

Secondary

MeasureTime frameDescription
overall survivalone yeartime between inclusion and the death whatever the cause
disease-free survivalone yeartime between inclusion and the progression or death

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026