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

Non-small Cell Lung Carcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664792
• Other study ID #: LACOG 0114
• Status: Completed
• Phase: N/A
• First received: January 22, 2016
• Last updated: February 22, 2017
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto do Cérebro do Rio Grande do Sul	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Instituto do Cérebro do Rio Grande do Sul - InsCer

Country where clinical trial is conducted

Brazil, 

References & Publications (19)

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Product Information: Fludeoxyglucose F18 IV injection, Fludeoxyglucose F18 IV injection. Feinstein Institute for Medical Research, Manhasset, NY, 2010.

Singh J, Daftary A. Iodinated contrast media and their adverse reactions. J Nucl Med Technol. 2008 Jun;36(2):69-74; quiz 76-7. doi: 10.2967/jnmt.107.047621. Review. — View Citation

Sommer G, Wiese M, Winter L, Lenz C, Klarhöfer M, Forrer F, Lardinois D, Bremerich J. Preoperative staging of non-small-cell lung cancer: comparison of whole-body diffusion-weighted magnetic resonance imaging and 18F-fluorodeoxyglucose-positron emission tomography/computed tomography. Eur Radiol. 2012 Dec;22(12):2859-67. doi: 10.1007/s00330-012-2542-y. — View Citation

VALLABHAJOSULA, S. Molecular Imaging: radiopharmaceuticals for PET and SPECT. New York: Springer, 2009. 371p.

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis		4 years
Secondary	Number of patients diagnosed in a positive manner with the gold standard and with the alternative method		up to 30 days following recruitment
Secondary	Number of patients with a negative diagnosis according to the gold standard and the alternative method		up to 30 days following recruitment
Secondary	Number of true positives among positive diagnosed patients with the alternative method		up to 30 days following recruitment
Secondary	Number of false positives among patients negatively diagnosed with the alternative method		up to 30 days following recruitment