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.
Verified January 2013 by European Lung Cancer Working Party
Sponsor:
Information provided by (Responsible Party):
European Lung Cancer Working Party
ClinicalTrials.gov Identifier:
NCT00759382
First received: September 24, 2008
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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).


Condition
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Period between the date of PET scan and the date of first progression or death ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • discriminant value of 18F-FDG uptake for survival and for PFS [ Time Frame: dated from PET examination ] [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: July 2008
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
I
Patients with non-small cell lung carcinoma treated with curative intent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759382

Contacts
Contact: MDNathalie Leclercq, RN 0032/2/5390496 nathalie.leclercq@bordet.be
Contact: Thierry Berghmans, MD 0032/2/5390496

Locations
Belgium
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
Investigators
Study Chair: Thierry Berghmans, MD European Lung Cancer Working Party
  More Information

Additional Information:
No publications provided

Responsible Party: European Lung Cancer Working Party
ClinicalTrials.gov Identifier: NCT00759382     History of Changes
Other Study ID Numbers: 01071
Study First Received: September 24, 2008
Last Updated: January 28, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014