Non Small Cell Lung CancerPARAPETNCT02821936
Parametric Imaging in Positron Emission Tomography for Patient With Lung Cancer
A study testing Parametric Imaging in people with Non Small Cell Lung Cancer, run by Centre Henri Becquerel at 2 sites in France.
Trial summary
The purpose of this study is to evaluate the concordance between Positron E mission tomography parametric imaging versus standard PET for the 1 year prognosis of patients with NSCLC treated by radiochemotherapy. 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?
- Parametric Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Jul 2016to 3 Jun 2020
- Phase
- Interventional
- 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 patient
- Age over 18 years old
- Histological evidence of non-small cell lung cancer
- Treatment by curative intent radio-chemotherapy based on platinum salt
- Stage superior or equal to T2a
- Tumour FDG uptake higher than mediastinal background noise on FDG PET/CT
- Affiliated or beneficiary of a social benefit system
Who cannot join
- Histology other than non-small cell lung cancer
- Patient without measurable target
- Absence of FDG uptake on FDG-PET/CT scan
- Previous neoplastic disease of less than 2 years duration or progressive
- Pregnant women or women of child-bearing potential or breast feeding mothers
- World Health Organisation scale superior or equal to 2
Show all 9Show fewer
- Adult subjects who are under protective custody or guardianship
- Patient unable to comply with the specific obligations of the study (geographic, social or physical reasons) Uncontrolled diabetes with blood glucose ≥10 mmol/L, Hypersensitivity to the active substance (FDG) or to any of the excipients, Patients unable to understand the purpose of the study (language, etc.)
- Unaffiliated or not beneficiary of a social benefit system
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Study of the Interest of the Parametric Imaging in Positron Emission Tomography on the Recurrence Prognosis at One Year in Patient With Non Small Cell Lung Cancer
The purpose of this study is to evaluate the concordance between Positron E mission tomography parametric imaging versus standard PET for the 1 year prognosis of patients with NSCLC treated by radiochemotherapy.
The ancillary study will evaluate the interest of parametric PET imaging during the treatment (around 42 Gray) to detect the local relapse of the lesion in order to propose a treatment re-planification or intensification (not realized on the present study).
Read the detailed description
In oncology, Positron Emission Tomography imaging with 18Fluor-FDG quantifies glucose metabolism lesions. Conventionally, the metabolism is quantified using the Standard Uptake Value (SUV) from a static acquisition obtained 60 minutes post-injection. Some teams reported SUV variation coefficients as high as 30% in NSCLC lesions for repeated PET examinations in patients without treatment. Moreover, information regarding the binding kinetics of 18Fluor-FDG by tumor cells is not accessible through this method.
Much more elaborated FDG quantification methods and considered as reference methods exist in PET imaging (compartmental analysis, Patlak). Simplified kinetic methods have also been proposed which correlate better with Patlak reference method than the conventional SUV. The investigators proposed a new methodological approach to obtain the parametric information in PET. This approach allows to define new indexes (average percentage of FDG-metabolized or not metabolized; time required to metabolize 80% of FDG). The approach has been clinically evaluated in a pilot study for the differentiation between benign and paraganglioma lesions.
Tsuchida observed that the parametric PET imaging allowed histological differentiation of subtypes of lung tumors, reflecting the difference in glucose transporters and hexokinase between adenocarcinoma and squamous cell carcinoma. Xue et al showed that the FDG uptake (based on the only SUV) could be a tool to predict the subtype and thus tumor staging in patients suffering from NSCLC.
The investigators can then hypothesize that some subtype of lung tumor, with increased proliferation rate (kinetic indexes k3, Ki or other parameters offered by our previous work), will be more sensitive to radiotherapy and thus the evaluation of tumor subtype by PET would allows radiotherapy adaption accordingly.
This study is a preliminary methodological study , strictly descriptive and will only assess the comparison of measurements obtained on a parametric imaging and imaging "static" in patients suffering from NSCLC . The measures of the uptake and volumes estimated by two approaches will be correlated and compared with the 1 year clinical outcome (primary objective).
An ancillary study will assess the relevance of the approach to detect, at the tumor level , an early recurrence of the disease. For this, the images acquired during the radiotherapy treatment (at 42Gy) will be analyzed retrospectively and the correlation with the images to 3 months or 1 year of relapsing patients will be analyzed.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Parametric Imaging
- Keywords
- positron emission tomography, parametric imaging, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parametric ImagingProcedure or surgery
2 parametric PET (one at the inclusion and one at 42 gray of the beginning of radiotherapy)
| Study group | Role | What they receive |
|---|---|---|
| Parametric Imaging | Experimental | one parametric PET at the inclusion and one at 42 Gray after the beginning of radiotherapy.
Two PET scans at 3 months and one year after inclusion Receives: Procedure: Parametric Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis of recurrence
Comparison between parametric Imaging and standard Imaging in PET for the diagnosis of recurrence
Measured: one year
Secondary outcomes (2)
analysis method of Parametric Imaging quantification determination
Determinate a method of analysis of the quantification of the parametric imaging
Measured: one year
recurrence-free survival predictive value determination
Evaluate the predictive value of the technique of parametric Imaging on the recurrence-free survival at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start13 Jul 2016
- Primary completion3 Jun 2020
- Study completion3 Jun 2020
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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille
- Responsible party
- Sponsor
- Investigators
- Pierre Vera, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821936
- Sponsor's protocol ID
- CHB15.03
- Acronym
- PARAPET
- Status last verified
- Dec 2025
- First submitted
- 20 Jun 2016
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Colard E, Delcourt S, Padovani L, Thureau S, Dumouchel A, Gouel P, Lequesne J, Ara BF, Vera P, Taieb D, Gardin I, Barbolosi D, Hapdey S. A new methodology to derive 3D kinetic parametric FDG PET images based on a mathematical approach integrating an error model of measurement. EJNMMI Res. 2018 Nov 15;8(1):99. doi: 10.1186/s13550-018-0454-9.
PubMed 30443801
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Interest of the Parametric Imaging in Positron Emission Tomography on the Recurrence Prognosis at One Year in Patient With Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02821936
- Acronym / sponsor ID
- PARAPET / CHB15.03
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- positron emission tomography, parametric imaging, lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille
- Study start
- 13 Jul 2016 (actual)
- Primary completion
- 3 Jun 2020 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 4 Jul 2016 (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 this study is to evaluate the concordance between Positron E mission tomography parametric imaging versus standard PET for the 1 year prognosis of patients with NSCLC treated by radiochemotherapy.
The ancillary study will evaluate the interest of parametric PET imaging during the treatment (around 42 Gray) to detect the local relapse of the lesion in order to propose a treatment re-planification or intensification (not realized on the present study).
Detailed description
In oncology, Positron Emission Tomography imaging with 18Fluor-FDG quantifies glucose metabolism lesions. Conventionally, the metabolism is quantified using the Standard Uptake Value (SUV) from a static acquisition obtained 60 minutes post-injection. Some teams reported SUV variation coefficients as high as 30% in NSCLC lesions for repeated PET examinations in patients without treatment. Moreover, information regarding the binding kinetics of 18Fluor-FDG by tumor cells is not accessible through this method.
Much more elaborated FDG quantification methods and considered as reference methods exist in PET imaging (compartmental analysis, Patlak). Simplified kinetic methods have also been proposed which correlate better with Patlak reference method than the conventional SUV. The investigators proposed a new methodological approach to obtain the parametric information in PET. This approach allows to define new indexes (average percentage of FDG-metabolized or not metabolized; time required to metabolize 80% of FDG). The approach has been clinically evaluated in a pilot study for the differentiation between benign and paraganglioma lesions.
Tsuchida observed that the parametric PET imaging allowed histological differentiation of subtypes of lung tumors, reflecting the difference in glucose transporters and hexokinase between adenocarcinoma and squamous cell carcinoma. Xue et al showed that the FDG uptake (based on the only SUV) could be a tool to predict the subtype and thus tumor staging in patients suffering from NSCLC.
The investigators can then hypothesize that some subtype of lung tumor, with increased proliferation rate (kinetic indexes k3, Ki or other parameters offered by our previous work), will be more sensitive to radiotherapy and thus the evaluation of tumor subtype by PET would allows radiotherapy adaption accordingly.
This study is a preliminary methodological study , strictly descriptive and will only assess the comparison of measurements obtained on a parametric imaging and imaging "static" in patients suffering from NSCLC . The measures of the uptake and volumes estimated by two approaches will be correlated and compared with the 1 year clinical outcome (primary objective).
An ancillary study will assess the relevance of the approach to detect, at the tumor level , an early recurrence of the disease. For this, the images acquired during the radiotherapy treatment (at 42Gy) will be analyzed retrospectively and the correlation with the images to 3 months or 1 year of relapsing patients will be analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parametric Imaging | Experimental | Procedure: Parametric Imagingone parametric PET at the inclusion and one at 42 Gray after the beginning of radiotherapy. Two PET scans at 3 months and one year after inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patient
- Age over 18 years old
- Histological evidence of non-small cell lung cancer
- Treatment by curative intent radio-chemotherapy based on platinum salt
- Stage superior or equal to T2a
Key exclusion criteria (9 listed)
- Histology other than non-small cell lung cancer
- Patient without measurable target
- Absence of FDG uptake on FDG-PET/CT scan
- Previous neoplastic disease of less than 2 years duration or progressive
- Pregnant women or women of child-bearing potential or breast feeding mothers
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 |
|---|---|---|
| Parametric Imaging2 parametric PET (one at the inclusion and one at 42 gray of the beginning of radiotherapy) | Procedure or surgery | Parametric Imaging |
Primary outcome
Prognosis of recurrence
Time frame: one year
Comparison between parametric Imaging and standard Imaging in PET for the diagnosis of recurrence
2 secondary outcomes
analysis method of Parametric Imaging quantification determination
Time frame: one year
recurrence-free survival predictive value determination
Time frame: 3 months
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 2 Jan 2026.
- Derived from this study: PubMed 30443801Colard E, Delcourt S, Padovani L, Thureau S, Dumouchel A, Gouel P, Lequesne J, Ara BF, Vera P, Taieb D, Gardin I, Barbolosi D, Hapdey S. A new methodology to derive 3D kinetic parametric FDG PET images based on a mathematical approach integrating an error model of measurement. EJNMMI Res. 2018 Nov 15;8(1):99. doi: 10.1186/s13550-018-0454-9.
- Individual participant dataSharing planned: No
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
RecruitingObservational study
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
HER2-mutant Advanced Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
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 principal investigator
Centre Henri Becquerel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parametric Imaging in people with Non Small Cell Lung Cancer, run by Centre Henri Becquerel at 2 sites 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 7 inclusion and 9 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 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Prognosis of recurrence (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 NCT02821936, 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 2 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.