Non Small Cell Lung Carcinoma Clinical Trial
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.
NCT number | NCT00759382 |
Other study ID # | 01071 |
Secondary ID | |
Status | Active, not recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2008 |
Est. completion date | January 2022 |
Verified date | August 2021 |
Source | European Lung Cancer Working Party |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Active, not recruiting |
Enrollment | 340 |
Est. completion date | January 2022 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Department of Pneumology RHMS Hôpital de la Madeleine | Ath | |
Belgium | Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet | Brussels | |
Belgium | Department of Pneumology CHU Charleroi | Charleroi | |
Belgium | Department of Pneumology Hôpital Saint-Joseph | Gilly | |
Belgium | Hôpital Ambroise Paré | Mons | |
Belgium | Department of Pneumology Centre Hospitalier de Mouscron | Mouscron |
Lead Sponsor | Collaborator |
---|---|
European Lung Cancer Working Party |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | discriminant value of 18F-FDG uptake for survival and for PFS | dated from PET examination | ||
Primary | Survival | Survival will be dated from the date of PET scan | ||
Secondary | Progression-free survival | Period between the date of PET scan and the date of first progression or death |
Status | Clinical Trial | Phase | |
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Active, not recruiting |
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