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:
European Lung Cancer Working Party
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
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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 May 16, 2013