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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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by European Lung Cancer Working Party
Information provided by (Responsible Party):
European Lung Cancer Working Party Identifier:
First received: September 24, 2008
Last updated: August 9, 2016
Last verified: August 2016
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).

Non Small Cell Lung Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by European Lung Cancer Working Party:

Primary Outcome Measures:
  • Survival [ Time Frame: Survival will be dated from the date of PET scan ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Period between the date of PET scan and the date of first progression or death ]

Other Outcome Measures:
  • discriminant value of 18F-FDG uptake for survival and for PFS [ Time Frame: dated from PET examination ]

Estimated Enrollment: 340
Study Start Date: July 2008
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Patients with non-small cell lung carcinoma treated with curative intent


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00759382

Contact: MDNathalie Leclercq, RN 0032/2/5390496
Contact: Thierry Berghmans, MD 0032/2/5390496

Department of Pneumology RHMS Hôpital de la Madeleine Recruiting
Ath, Belgium, 7800
Contact: Pol Ravez, MD         
Principal Investigator: Pol Ravez, MD         
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Thierry Berghmans, MD    0032/2/5390496      
Principal Investigator: Thierry Berghmans, MD         
Department of Pneumology CHU Charleroi Recruiting
Charleroi, Belgium, 6000
Contact: Jacques Lecomte, MD         
Principal Investigator: Jacques Lecomte, MD         
Department of Pneumology Hôpital Saint-Joseph Recruiting
Gilly, Belgium, 6060
Contact: Benoît Colinet, MD         
Principal Investigator: Benoît Colinet, MD         
Hôpital Ambroise Paré Recruiting
Mons, Belgium, 7000
Contact: Stéphane Holbrechts, MD         
Sub-Investigator: Patricia Wackenier, MD         
Principal Investigator: Stéphane Holbrechts, MD         
Department of Pneumology Centre Hospitalier de Mouscron Recruiting
Mouscron, Belgium, 7700
Contact: Christian Tulippe, MD         
Principal Investigator: Christian Tulippe, MD         
Sponsors and Collaborators
European Lung Cancer Working Party
Study Chair: Thierry Berghmans, MD European Lung Cancer Working Party
  More Information

Responsible Party: European Lung Cancer Working Party Identifier: NCT00759382     History of Changes
Other Study ID Numbers: 01071
Study First Received: September 24, 2008
Last Updated: August 9, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by European Lung Cancer Working Party:
Non small cell lung carcinoma
PET scan
Observational study
Non metastatic
curative intent

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents processed this record on April 26, 2017