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

February 22, 2017 updated by: Latin American Cooperative Oncology Group

Use of [18]F-FDG - PET/CT in Brazil Unified Health System (SUS) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Instituto do Cerebro do Rio Grande do Sul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
up to 30 days following recruitment
Number of patients with a negative diagnosis according to the gold standard and the alternative method
Time Frame: up to 30 days following recruitment
up to 30 days following recruitment
Number of true positives among positive diagnosed patients with the alternative method
Time Frame: up to 30 days following recruitment
up to 30 days following recruitment
Number of false positives among patients negatively diagnosed with the alternative method
Time Frame: up to 30 days following recruitment
up to 30 days following recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Latin American Cooperative Oncology Group

Collaborators

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

Investigators

  • Study Director: Gustavo Werutsky, MD, Latin American Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACOG 0114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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