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

NCT02664792 | Completed

• 1 other identifier: LACOG 0114
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Carcinoma

Keywords

Non-small cell lung carcinoma; PET/CT; 18F-FDG

Outcome Measures

Primary Outcomes (1)

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

  4 years

Secondary Outcomes (4)

• 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

• 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

Study Arms (1)

Diagnosis or suspicion of non-small cell lung carcinoma

EXPERIMENTAL

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

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

Interventions

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

Diagnosis or suspicion of non-small cell lung carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Patients with other types of patients

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead
• Instituto do Cérebro do Rio Grande do Sul - InsCer: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Instituto do Cérebro do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (20)

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gustavo Werutsky, MD

  Latin American Cooperative Oncology Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 27, 2016
• Study Start: August 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

BR (1)