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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014