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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.

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ClinicalTrials.gov Identifier: NCT00759382
Recruitment Status : Active, not recruiting
First Posted : September 25, 2008
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
European Lung Cancer Working Party

Study Description
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Brief Summary:
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 or disease
Non Small Cell Lung Carcinoma

Study Design
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Study Type : Observational
Estimated Enrollment : 340 participants
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.
Study Start Date : July 2008
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

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


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

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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759382


Locations
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Belgium
Department of Pneumology RHMS Hôpital de la Madeleine
Ath, Belgium, 7800
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
Department of Pneumology CHU Charleroi
Charleroi, Belgium, 6000
Department of Pneumology Hôpital Saint-Joseph
Gilly, Belgium, 6060
Hôpital Ambroise Paré
Mons, Belgium, 7000
Department of Pneumology Centre Hospitalier de Mouscron
Mouscron, Belgium, 7700
Sponsors and Collaborators
European Lung Cancer Working Party
Investigators
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Study Chair: Thierry Berghmans, MD European Lung Cancer Working Party
More Information
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Responsible Party: European Lung Cancer Working Party
ClinicalTrials.gov Identifier: NCT00759382    
Other Study ID Numbers: 01071
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms