Parametric Imaging in Positron Emission Tomography for Patient With Lung Cancer (PARAPET)
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|ClinicalTrials.gov Identifier: NCT02821936|
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : July 24, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Procedure: Parametric Imaging||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: Parametric Imaging
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
Procedure: Parametric Imaging
2 parametric PET (one at the inclusion and one at 42 gray of the beginning of radiotherapy)
- Prognosis of recurrence [ Time Frame: one year ]Comparison between parametric Imaging and standard Imaging in PET for the diagnosis of recurrence
- analysis method of Parametric Imaging quantification determination [ Time Frame: one year ]Determinate a method of analysis of the quantification of the parametric imaging
- recurrence-free survival predictive value determination [ Time Frame: 3 months ]Evaluate the predictive value of the technique of parametric Imaging on the recurrence-free survival at 3 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821936
|Contact: Sebastien Hapdey, PhDemail@example.com|
|Contact: Doriane Richard, PhDfirstname.lastname@example.org|
|Marseille, France, 13000|
|Contact: Laetitia Padovani, MD|
|Principal Investigator: Laetitia Padovani, MD|
|Centre Henri Becquerel||Recruiting|
|Rouen, France, 76000|
|Contact: Sebastien Hapdey, PhD +33232082478 email@example.com|
|Principal Investigator: Pierre Vera, PhD; MD|
|Principal Investigator:||Pierre Vera, MD||Centre Henri Becquerel|