Non-small Cell Lung Carcinoma
Conditions
Keywords
Non-small cell lung carcinoma, PET/CT, 18F-FDG
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
Interventions
OTHERUse of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma
Sponsors
Instituto do Cérebro do Rio Grande do Sul - InsCer
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Latin American Cooperative Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individuals with histological diagnosis or high suspicion of non-small cell lung carcinoma 2. Patients who previously underwent staging of the disease with CT 3. Clinical stages I-III AJCC 7th edition. 4. Patients with indication for mediastinoscopy and linfonodal biopsy 5. Patients without treatment for lung cancer 6. Patients with biochemical and haematological exams 7. Women of childbearing potential using contraceptive methods and negative pregnancy test 8. Adults with more than 18 years old. 9. Both genders
Exclusion criteria
* Pregnant women * Patients with other types of patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis | 4 years |
Secondary
| Measure | 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 |
Countries
Brazil
Outcome results
None listed