Overview

This trial is active, not recruiting.

Condition non-small cell lung carcinoma
Treatment use of [18f]fdg - pet/ct for the diagnosis and staging of non-small cell lung carcinoma
Sponsor Latin American Cooperative Oncology Group
Collaborator Instituto do Cérebro do Rio Grande do Sul - InsCer
Start date August 2014
End date August 2016
Trial size 108 participants
Trial identifier NCT02664792, LACOG 0114

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
SUS patients with diagnosis or suspicion of non-small cell lung carcinoma with an indication for mediastinoscopy
use of [18f]fdg - pet/ct for the diagnosis and staging of non-small cell lung carcinoma

Primary Outcomes

Measure
Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis
time frame: 4 years

Secondary Outcomes

Measure
Number of patients diagnosed in a positive manner with the gold standard and with the alternative method
time frame: up to 30 days following recruitment
Number of patients with a negative diagnosis according to the gold standard and the alternative method
time frame: up to 30 days following recruitment
Number of true positives among positive diagnosed patients with the alternative method
time frame: up to 30 days following recruitment
Number of false positives among patients negatively diagnosed with the alternative method
time frame: up to 30 days following recruitment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Latin American Cooperative Oncology Group.