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

NCT ID: NCT02664792

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-12-31

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

Conditions

Non-small Cell Lung Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnosis or suspicion of non-small cell lung carcinoma

SUS patients with diagnosis or suspicion of non-small cell lung carcinoma with an indication for mediastinoscopy

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cérebro do Rio Grande do Sul - InsCer

UNKNOWN

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Latin American Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gustavo Werutsky, MD

Role: STUDY_DIRECTOR

Latin American Cooperative Oncology Group

Locations

Instituto do Cérebro do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

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Other Identifiers

LACOG 0114

Identifier Type: -

Identifier Source: org_study_id