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.
Conditions
Non Small Cell Lung Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Non small cell lung carcinoma, PET scan, Observational study, Non metastatic, treated, curative intent
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Department of Pneumology RHMS Hôpital de la Madeleine
Ath, Belgium
Status: Recruiting
Contact: Pol Ravez, MD
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium
Status: Recruiting
Contact: Thierry Berghmans, MD - 0032/2/5390496
Department of Pneumology CHU Charleroi
Charleroi, Belgium
Status: Recruiting
Contact: Jacques Lecomte, MD
Department of Pneumology Hôpital Saint-Joseph
Gilly, Belgium
Status: Recruiting
Contact: Benoît Colinet, MD
Hôpital Ambroise Paré
Mons, Belgium
Status: Recruiting
Contact: Stéphane Holbrechts, MD
Department of Pneumology Centre Hospitalier de Mouscron
Mouscron, Belgium
Status: Recruiting
Contact: Christian Tulippe, MD
Start Date
July 2008
Completion Date
January 2020
Sponsors
European Lung Cancer Working Party
Source
European Lung Cancer Working Party
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page