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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
Sponsor:
Collaborator:
Assistance Publique Hopitaux De Marseille
Information provided by (Responsible Party):
Centre Henri Becquerel

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).


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Procedure: Parametric Imaging Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Prognosis of recurrence [ Time Frame: one year ]
    Comparison between parametric Imaging and standard Imaging in PET for the diagnosis of recurrence


Secondary Outcome Measures :
  1. analysis method of Parametric Imaging quantification determination [ Time Frame: one year ]
    Determinate a method of analysis of the quantification of the parametric imaging

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Sebastien Hapdey, PhD +33232082478 sebastien.hapdey@chb.unicancer.fr
Contact: Doriane Richard, PhD +33232082985 doriane.richard@chb.unicancer.fr

Locations
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France
APHM Recruiting
Marseille, France, 13000
Contact: Laetitia Padovani, MD         
Principal Investigator: Laetitia Padovani, MD         
Centre Henri Becquerel Recruiting
Rouen, France, 76000
Contact: Sebastien Hapdey, PhD    +33232082478    sebatien.hapdey@chb.unicancer.fr   
Principal Investigator: Pierre Vera, PhD; MD         
Sponsors and Collaborators
Centre Henri Becquerel
Assistance Publique Hopitaux De Marseille
Investigators
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Principal Investigator: Pierre Vera, MD Centre Henri Becquerel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT02821936     History of Changes
Other Study ID Numbers: CHB15.03
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Henri Becquerel:
positron emission tomography
parametric imaging
lung cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms