Non-small Cell Lung CancerPhase 2RTEP6NCT02490696
Comparative Study of the Hypoxia Measured in FAZA and F-miso PET/CT Scan in Patients With Non-small Cell Lung Cancer
A Phase 2 study testing Miso PET scan and FAZA PET scan in people with Non-small Cell Lung Cancer, run by Centre Henri Becquerel at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Miso PET scan and FAZA PET scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2015to Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Miso PET scan, FAZA PET scan
- Keywords
- PET scan, FAZA, F-Miso, hypoxia, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Hypoxia, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miso PET scanDevice
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 scanDevice
2 PET scans will be performed before surgery : the first one with FAZA tracer and the second, 24 hours later, with F-Miso tracer
| Study group | Role | What they receive |
|---|---|---|
| Miso | Experimental | 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 Receives: Device: Miso PET scan |
| FAZA | Experimental | 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 Receives: Device: FAZA PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (2)
overall survival
time between inclusion and the death whatever the cause
Measured: one year
disease-free survival
time between inclusion and the progression or death
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study start1 Jun 2015
- Primary completionDec 2018
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Vera, MD, PhD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490696
- Sponsor's protocol ID
- CHB14.01
- Acronym
- RTEP6
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2015
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32399752
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02490696
- Acronym / sponsor ID
- RTEP6 / CHB14.01
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- PET scan, FAZA, F-Miso, hypoxia, lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miso | Experimental | Device: Miso PET scanIn 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 | Experimental | Device: FAZA PET scanIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miso PET scan2 PET scans will be performed before surgery : the first one with F-Miso tracer and the second, 24 hours later, with FAZA tracer | Device | Miso |
| FAZA PET scan2 PET scans will be performed before surgery : the first one with FAZA tracer and the second, 24 hours later, with F-Miso tracer | Device | FAZA |
Primary outcome
Comparison of hypoxia with FAZA and F-Miso tracer
Time frame: 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
2 secondary outcomes
overall survival
Time frame: one year
disease-free survival
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Derived from this study: PubMed 32399752Texte 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Vera, MD, PhD principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Miso PET scan and FAZA PET scan in people with Non-small Cell Lung Cancer, run by Centre Henri Becquerel at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of hypoxia with FAZA and F-Miso tracer (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02490696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.