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Completed

NCT Number: NCT02664792

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

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.

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Key information

Conditions

Non-small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto do Cérebro do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with histological diagnosis or high suspicion of non-small cell lung carcinoma
  • Patients who previously underwent staging of the disease with CT
  • Clinical stages I-III AJCC 7th edition.
  • Patients with indication for mediastinoscopy and linfonodal biopsy
  • Patients without treatment for lung cancer
  • Patients with biochemical and haematological exams
  • Women of childbearing potential using contraceptive methods and negative pregnancy test
  • Adults with more than 18 years old.
  • Both genders

Exclusion criteria

  • Pregnant women
  • Patients with other types of patients

Treatment and study plan

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

Other

Primary outcomes

  1. Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis

    Time frame: 4 years

Secondary outcomes

  1. 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

  2. Number of patients with a negative diagnosis according to the gold standard and the alternative method

    Time frame: up to 30 days following recruitment

  3. Number of true positives among positive diagnosed patients with the alternative method

    Time frame: up to 30 days following recruitment

  4. Number of false positives among patients negatively diagnosed with the alternative method

    Time frame: up to 30 days following recruitment

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Instituto do Cérebro do Rio Grande do Sul - InsCer

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 27, 2016
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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