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 ID: NCT00759382

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2022-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Non Small Cell Lung Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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I

Patients with non-small cell lung carcinoma treated with curative intent

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Lung Cancer Working Party

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry Berghmans, MD

Role: STUDY_CHAIR

European Lung Cancer Working Party

Locations

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Department of Pneumology RHMS Hôpital de la Madeleine

Ath, , Belgium

Site Status

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, , Belgium

Site Status

Department of Pneumology CHU Charleroi

Charleroi, , Belgium

Site Status

Department of Pneumology Hôpital Saint-Joseph

Gilly, , Belgium

Site Status

Hôpital Ambroise Paré

Mons, , Belgium

Site Status

Department of Pneumology Centre Hospitalier de Mouscron

Mouscron, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.elcwp.org

Click here for more information on the protocol

Other Identifiers

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01071

Identifier Type: -

Identifier Source: org_study_id

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