NCT02821936

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

July 13, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2020

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

3.9 years

First QC Date

June 20, 2016

Last Update Submit

December 29, 2025

Conditions

Non Small Cell Lung Cancer

Keywords

positron emission tomographyparametric imaginglung cancer

Outcome Measures

Primary Outcomes (1)

  • Prognosis of recurrence

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

    one year

Secondary Outcomes (2)

  • analysis method of Parametric Imaging quantification determination

    one year

  • recurrence-free survival predictive value determination

    3 months

Study Arms (1)

Parametric Imaging

EXPERIMENTAL

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

Interventions

Parametric ImagingPROCEDURE

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

Parametric Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

APHM

Marseille, 13000, France

Location

Centre Henri Becquerel

Rouen, 76000, France

Location

Related Publications (1)

  • 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.

    PMID: 30443801DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pierre Vera, MD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

July 4, 2016

Study Start

July 13, 2016

Primary Completion

June 3, 2020

Study Completion

June 3, 2020

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)