Back to resultsComparative Study of the Hypoxia Measured in FAZA and F-miso PET/CT Scan in Patients With Non-small Cell Lung Cancer (RTEP6)
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Miso PET scan
FAZA PET scan
Sponsored by
About this trial
This is an interventional other trial for Non-small Cell Lung Cancer focused on measuring PET scan, FAZA, F-Miso, hypoxia, lung cancer
Eligibility Criteria
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
Sites / Locations
- Centre Henri Becquerel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Miso
FAZA
Arm 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
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
Outcomes
Primary Outcome Measures
Comparison of hypoxia with FAZA and F-Miso tracer
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
overall survival
time between inclusion and the death whatever the cause
disease-free survival
time between inclusion and the progression or death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02490696
Brief Title
Comparative Study of the Hypoxia Measured in FAZA and F-miso PET/CT Scan in Patients With Non-small Cell Lung Cancer
Acronym
RTEP6
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
PET scan, FAZA, F-Miso, hypoxia, lung cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Miso
Arm Type
Experimental
Arm 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
Arm Title
FAZA
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Miso PET scan
Intervention Description
2 PET scans will be performed before surgery : the first one with F-Miso tracer and the second, 24 hours later, with FAZA tracer
Intervention Type
Device
Intervention Name(s)
FAZA PET scan
Intervention Description
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 Outcome Measure Information:
Title
Comparison of hypoxia with FAZA and F-Miso tracer
Description
SUV max, SUV mean and SUV peak were calculated for FAZA PET and Fmiso PET and will be correlated with results of immunohistochemistry
Time Frame
one year
Secondary Outcome Measure Information:
Title
overall survival
Description
time between inclusion and the death whatever the cause
Time Frame
one year
Title
disease-free survival
Description
time between inclusion and the progression or death
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Vera, MD, PhD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32399752
Citation
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.
Results Reference
derived
Learn more about this trial
Comparative Study of the Hypoxia Measured in FAZA and F-miso PET/CT Scan in Patients With Non-small Cell Lung Cancer
We'll reach out to this number within 24 hrs