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.

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00759382
• Other study ID #: 01071
• Status: Active, not recruiting
• Start date: July 2008
• Est. completion date: January 2022

Study information

• Verified date: August 2021
• Source: European Lung Cancer Working Party
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Carcinoma

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
European Lung Cancer Working Party

Country where clinical trial is conducted

Belgium, 

Outcome

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