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

L

Latin American Cooperative Oncology Group (LACOG)

Status

Completed

Conditions

Non-small Cell Lung Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02664792
LACOG 0114

Details and patient eligibility

About

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.

Full 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

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

108 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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