Clinical trial NCT02821936: Parametric Imaging in Positron Emission Tomography for Patient With Lung Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: positron emission tomography
parametric imaging
lung cancer
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
Collaborators: name: Assistance Publique Hopitaux De Marseille
First posted: 2016-07-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Prognosis of recurrence
timeFrame: one year
Secondary outcomes:
measure: analysis method of Parametric Imaging quantification determination
timeFrame: one year
measure: recurrence-free survival predictive value determination
timeFrame: 3 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Pierre Vera, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.