Comparative Study of the Hypoxia Measured in FAZA and F-miso PET/CT Scan in Patients With Non-small Cell Lung Cancer
NCT ID: NCT02490696
Last Updated: 2020-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2015-06-01
2019-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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
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
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centre Henri Becquerel
OTHER
Responsible Party
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Principal Investigators
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Pierre Vera, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Henri Becquerel
Locations
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Centre Henri Becquerel
Rouen, , France
Countries
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References
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Texte E, Gouel P, Thureau S, Lequesne J, Barres B, Edet-Sanson A, Decazes P, Vera P, Hapdey S. Impact of the Bayesian penalized likelihood algorithm (Q.Clear(R)) in comparison with the OSEM reconstruction on low contrast PET hypoxic images. EJNMMI Phys. 2020 May 12;7(1):28. doi: 10.1186/s40658-020-00300-3.
Other Identifiers
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CHB14.01
Identifier Type: -
Identifier Source: org_study_id
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