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Parametric Imaging in Positron Emission Tomography for Patient With Lung Cancer (PARAPET)

Primary Purpose

Non Small Cell Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Parametric Imaging
Sponsored by
Centre Henri Becquerel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Non Small Cell Lung Cancer focused on measuring positron emission tomography, parametric imaging, lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • APHMRecruiting
  • Centre Henri BecquerelRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parametric Imaging

Arm Description

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

Outcomes

Primary Outcome Measures

Prognosis of recurrence
Comparison between parametric Imaging and standard Imaging in PET for the diagnosis of recurrence

Secondary Outcome Measures

analysis method of Parametric Imaging quantification determination
Determinate a method of analysis of the quantification of the parametric imaging
recurrence-free survival predictive value determination
Evaluate the predictive value of the technique of parametric Imaging on the recurrence-free survival at 3 months

Full Information

First Posted
June 20, 2016
Last Updated
July 20, 2018
Sponsor
Centre Henri Becquerel
Collaborators
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02821936
Brief Title
Parametric Imaging in Positron Emission Tomography for Patient With Lung Cancer
Acronym
PARAPET
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
Collaborators
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
positron emission tomography, parametric imaging, lung cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parametric Imaging
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Parametric Imaging
Intervention Description
2 parametric PET (one at the inclusion and one at 42 gray of the beginning of radiotherapy)
Primary Outcome Measure Information:
Title
Prognosis of recurrence
Description
Comparison between parametric Imaging and standard Imaging in PET for the diagnosis of recurrence
Time Frame
one year
Secondary Outcome Measure Information:
Title
analysis method of Parametric Imaging quantification determination
Description
Determinate a method of analysis of the quantification of the parametric imaging
Time Frame
one year
Title
recurrence-free survival predictive value determination
Description
Evaluate the predictive value of the technique of parametric Imaging on the recurrence-free survival at 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastien Hapdey, PhD
Phone
+33232082478
Email
sebastien.hapdey@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Vera, MD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
APHM
City
Marseille
ZIP/Postal Code
13000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laetitia Padovani, MD
First Name & Middle Initial & Last Name & Degree
Laetitia Padovani, MD
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastien Hapdey, PhD
Phone
+33232082478
Email
sebatien.hapdey@chb.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Pierre Vera, PhD; MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30443801
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.
Results Reference
derived

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Parametric Imaging in Positron Emission Tomography for Patient With Lung Cancer

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