Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.

August 20, 2021 updated by: European Lung Cancer Working Party
The primary aim of this non interventional study is to assess the independent prognostic role on overall survival of primary tumour 18F-FDG uptake value (SUVmax) measured on 18fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in patients with non-metastatic non-small cell lung cancers treated with curative intent, taking into account the other conventional prognostic factors (performance status, age, sex, disease stage).

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ath, Belgium, 7800
        • Department of Pneumology RHMS Hôpital de la Madeleine
      • Brussels, Belgium, 1000
        • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
      • Charleroi, Belgium, 6000
        • Department of Pneumology CHU Charleroi
      • Gilly, Belgium, 6060
        • Department of Pneumology Hôpital Saint-Joseph
      • Mons, Belgium, 7000
        • Hopital Ambroise Pare
      • Mouscron, Belgium, 7700
        • Department of Pneumology Centre Hospitalier de Mouscron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients presenting with non metastatic non small cell lung carcinoma, treated in the participating centres with curative intent

Description

Inclusion Criteria:

  • Pathologically demonstrated NSCLC
  • Stage I-III treated by curative treatment by surgery with or without chemotherapy (induction or adjuvant) or by chemoradiotherapy
  • Inoperable patients treated by exclusive radiotherapy
  • A whole-body (skull base to mid thighs) FDG-PET or a combined FDG-PET/CT on a dedicated machine, performed before any anticancer treatment
  • FDG-PET or combined FDG-PET/CT has to be previously standardised according to the procedure described in appendix IV
  • Written informed consent
  • Accessibility to follow-up
  • Age > 18 years

Exclusion Criteria:

  • Prior anticancer treatment (surgery, radiotherapy or chemotherapy)
  • Stage IV NSCLC
  • A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
  • Uncontrolled diabetes mellitus (fast glycaemia above 130 mg/dl)
  • Pregnancy and lactating woman
  • Unavailability to send a copy of the PET or PET-CT (DICOM format) to the data centre

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
I
Patients with non-small cell lung carcinoma treated with curative intent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: Survival will be dated from the date of PET scan
Survival will be dated from the date of PET scan

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Period between the date of PET scan and the date of first progression or death
Period between the date of PET scan and the date of first progression or death

Other Outcome Measures

Outcome Measure
Time Frame
discriminant value of 18F-FDG uptake for survival and for PFS
Time Frame: dated from PET examination
dated from PET examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Lung Cancer Working Party

Investigators

  • Study Chair: Thierry Berghmans, MD, European Lung Cancer Working Party

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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