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NCT Number: NCT02821936

Parametric Imaging in Positron Emission Tomography for Patient With 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

APHM, Marseille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parametric Imaging

Procedure

2 parametric PET (one at the inclusion and one at 42 gray of the beginning of radiotherapy)

Primary outcomes

  1. Prognosis of recurrence

    Time frame: one year

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Collaborators

  • Assistance Publique Hopitaux De Marseille

Registry information

Official study 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

Acronym: PARAPET

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 4, 2016
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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