Characteristics of Mediastinal Lymph Node With False Positive FDG PET/CT Results in Lung Cancer Staging : Relation With TB and Latent TB Infection

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01376856
First received: June 16, 2011
Last updated: June 1, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to analyze pathologic and radiologic characteristics of mediastinal lymph nodes with false positive FDG PET/CT results in lung cancer staging and assess relationship between false positive mediastinal lymph node and TB/latent TB.


Condition
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Characteristics of Mediastinal Lymph Node With False Positive FDG PET/CT Results in Lung Cancer Staging : Relation With TB and Latent TB Infection

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • false positive rate of Mediastinal Lymph Node [ Time Frame: 3months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood for perfoming Quantiferon-TB Gold in tube assay


Enrollment: 33
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
PET/CT and surgical biopsy group
person who performed PET/CT and surgical biopsy of mediastinal lymph node for diagnosis of primary lung cancer of metastatic lung cancer

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

person who performed PET/CT and surgical biposy of mediastinal lymph node for diagnosis of primary lung cancer of metastatic lung cancer

Criteria

Inclusion Criteria:

  • age 20-75, men and women
  • person who performed PET/CT and surgical biopsy of mediastinal lymph node for diagnosis of primary lung cancer of metastatic lung cancer

Exclusion Criteria:

  • age < 20
  • person who don't agree with enrollment
  • illiterate
  • person who is diagnosed as active tuberculosis now
  • person who has history of hypersensitivity on PPD (tuberculin purified protein derivative)
  • pregnant woman
  • person who is treated as active tuberculosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376856

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01376856     History of Changes
Other Study ID Numbers: 4-2011-0196
Study First Received: June 16, 2011
Last Updated: June 1, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
mediastinal lymph node with false positive FDG PET/CT results in lung cancer staging

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014