Dx Mediastinal Malignant LAP:Compare PET and EBUS-TBNA

NCT01367366 | Unknown

• 1 other identifier: 201004018R
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is the leading cause of death in Taiwan. The outcomes of the disease vary depending on early detection, histologic types and staging. Because the mediastinal involvement including lymph node status is a significant prognostic factor for survival, lymph node biopsy is necessary for clinical staging of some patients. Although fluorodeoxyglucose-positron emission tomography (FDG-PET) is suggested for precise evaluation of mediastinum, tissue proof of PET positive lesions are recommended due to its limited diagnostic specificity for identifying mediastinal metastases. Cervical mediastinoscopy remains the "gold standard" for mediastinal lymph node sampling. However, it is invasive, requires general anesthesia. Another new minimally invasive method of mediastinal biopsy is real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). The aim of this study is to compare the accuracy of PET and EBUS-TBNA for correct staging of the mediastinum for lung cancer patients.

Conditions

Mediastinal Lymphadenopathy

Keywords

malignant mediastinal lymphadenopathy; positron emission tomography; endobronchial ultrasound; transbronchial needle aspiration

Outcome Measures

Primary Outcomes (1)

• Diagnostic value of PET and EBUS-TBNA

  Thg diagnostic criteria for malignant mediastinal lymphadenopathy is as followed: 1. EBUS-TBNA: postive cytology or patholoy result of the culprit lymph node 2. PET: SUVmax \>2.5 of the culprit lymph node The gold standard diagnostic method is surgical biopsy of the culprit lymph node. The sensitivity,specificity,positive and negative predictive value will be calculated.

  1 week

Study Arms (1)

Mediastinal malignant lymphadenopathy

Procedure: PET and EBUS-TBNA

Interventions

PET and EBUS-TBNA PROCEDURE

PET and EBUS-TBNA once, respectively

Mediastinal malignant lymphadenopathy

Eligibility Criteria

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

Study Population

Suspected malignant mediastinal lymphadenopathy

You may qualify if:

• Age older than 18 years
• Patient with suspected malignant mediastinal lymphadenopathy

You may not qualify if:

• Age younger than 18 years
• Bleeding diathesis(INR \> 1.4, Platelet count \< 10,000/mcl)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Study Officials

• Chao-Chi Ho, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Chi Ho, PhD

CONTACT

886-972651317; ccho1203@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: June 7, 2011
• Study Start: May 1, 2010
• Primary Completion: April 1, 2012
• Last Updated: June 7, 2011

Record last verified: 2011-05

Locations

TW (1)