Use of [18]F-FDG on PET/CT as an Alternative Non-invasive Method for Staging of Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the diagnostic accuracy of the 18Fluor-fluorodeoxyglucose ([18F]FDG) in the Positron Emission Tomography/Computed Tomography (PET/CT) as compared to mediastinoscopy for staging of non-small cel lung carcinoma.

Detailed Description
-----------------
The main aim of this study is to validate the [18F]FDG on PET/CT for the diagnosis of metastatic ganglions at the mediastinum in SUS patients with non-small cell lung carcinoma considering sensitivity, specificity, positive predictive value, negative predictive value, accuracy. Other specific aims are: Analyze the diagnosis performance of the [18F]FDG on PET/CT in two timepoints (1 and 2 hours after exam), in relation to the staging of the non-small cell lung carcinoma Evaluate the addition of the iodinated contrast in the [18F]FDG to improve the images obtained from the PET/CT in the staging of the non-small cell lung carcinoma

Official Title
-----------------
Use of [18]F-FDG - PET/CT in Brazil Unified Health System (SUS) as an Alternative Non-invasive Method for Staging of Lung Cancer

Conditions
-----------------
Non-small Cell Lung Carcinoma

Intervention / Treatment
-----------------
* Other: Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with histological diagnosis or high suspicion of non-small cell lung carcinoma Patients who previously underwent staging of the disease with CT Clinical stages I-III AJCC 7th edition. Patients with indication for mediastinoscopy and linfonodal biopsy Patients without treatment for lung cancer Patients with biochemical and haematological exams Women of childbearing potential using contraceptive methods and negative pregnancy test Adults with more than 18 years old. Both genders Exclusion Criteria: Pregnant women Patients with other types of patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnosis or suspicion of non-small cell lung carcinoma<br>SUS patients with diagnosis or suspicion of non-small cell lung carcinoma with an indication for mediastinoscopy | Other: Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients diagnosed in a positive manner with the gold standard and with the alternative method |  | up to 30 days following recruitment | 
| Number of patients with a negative diagnosis according to the gold standard and the alternative method |  | up to 30 days following recruitment | 
| Number of true positives among positive diagnosed patients with the alternative method |  | up to 30 days following recruitment | 
| Number of false positives among patients negatively diagnosed with the alternative method |  | up to 30 days following recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET/CT, Non-small cell lung carcinoma, 18F-FDG