Clinical trial NCT02664792: Use of [18]F-FDG on PET/CT as an Alternative Non-invasive Method for Staging of Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Carcinoma
Keywords: Non-small cell lung carcinoma
PET/CT
18F-FDG
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Instituto do Cérebro do Rio Grande do Sul - InsCer
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-01-27
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis
timeFrame: 4 years
Secondary outcomes:
measure: Number of patients diagnosed in a positive manner with the gold standard and with the alternative method
timeFrame: up to 30 days following recruitment
measure: Number of patients with a negative diagnosis according to the gold standard and the alternative method
timeFrame: up to 30 days following recruitment
measure: Number of true positives among positive diagnosed patients with the alternative method
timeFrame: up to 30 days following recruitment
measure: Number of false positives among patients negatively diagnosed with the alternative method
timeFrame: up to 30 days following recruitment
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto do Cérebro do Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Gustavo Werutsky, MD
role: STUDY_DIRECTOR
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