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

Not Applicable

Completed

• Conditions: Non-small Cell Lung Carcinoma
• Interventions: Other: Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma

• Registration Number: NCT02664792
• Lead Sponsor: Latin American Cooperative Oncology Group

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

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Primary Completion: 2016-07
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnosis or suspicion of non-small cell lung carcinoma	Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma	SUS patients with diagnosis or suspicion of non-small cell lung carcinoma with an indication for mediastinoscopy

Primary Outcome Measures

Name	Time	Method
Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis	4 years

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Instituto do Cérebro do Rio Grande do Sul; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil