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

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).

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Procedure: Parametric Imaging

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastien Hapdey, PhD; Phone Number: +33232082478; Email: sebastien.hapdey@chb.unicancer.fr

Study Locations

• France
  • Marseille, France, 13000
    • Recruiting
    • APHM
    • Contact: Laetitia Padovani, MD
    • Principal Investigator: Laetitia Padovani, MD
  • Rouen, France, 76000
    • Recruiting
    • Centre Henri Becquerel
    • Contact: Sebastien Hapdey, PhD; Phone Number: +33232082478; Email: sebatien.hapdey@chb.unicancer.fr
    • Principal Investigator: Pierre Vera, PhD; MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognosis of recurrence	Comparison between parametric Imaging and standard Imaging in PET for the diagnosis of recurrence	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analysis method of Parametric Imaging quantification determination	Determinate a method of analysis of the quantification of the parametric imaging	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	3 months

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Collaborators: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: Pierre Vera, MD, Centre Henri Becquerel

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: lung cancer; positron emission tomography; parametric imaging
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CHB15.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO