Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA) for Mediastinal Re-staging of Non-small Cell Lung Cancer(NSCLC)

NCT00859742 | Withdrawn DMC

• 1 other identifier: NCCTS-06-211
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in patients with non-small cell lung cancer. Primary objective: 1\. To determine the sensitivity, specificity, positive predictive value, negative predictive value and the accuracy of EBUS-TBNA in the detection of mediastinal metastasis in mediastinal re-staging after induction treatment. Secondary objectives:

1. 1.To compare the diagnostic values of EBUS-TBNA and integrated PET/CT in mediastinal re-staging
2. 2.To evaluate the changes of ultrasonographic features of mediastinal lymph nodes after induction therapy
3. 3.To determine procedure related complications

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer.

  1.5 years

Secondary Outcomes (2)

• The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer

  1.5 years

• The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy

  1.5 years

Study Arms (1)

EBUS-TBNA

EXPERIMENTAL

Procedure: EBUS-TBNA, integrated PET/CT

Interventions

EBUS-TBNA, integrated PET/CT PROCEDURE

EBUS-TBNA and integrated PET/CT will be performed for patients with non-small cell lung cancer after induction therapy. PET/CT will be performed before EBUS-TBNA. Negative findings of EBUS-TBNA will be evaluated by surgery.

EBUS-TBNA

Eligibility Criteria

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

You may qualify if:

• Histologically proven non-small cell lung cancer
• Patients who have initially histologically proven N2 disease (Stage IIIA)
• Patients who underwent induction treatment (chemotherapy or chemoradiation therapy) and are considred for surgery
• Written informed consent

You may not qualify if:

• Contraindications for bronchoscopy
• Medically inoperable patients
• Patients who are found to have M1 disease, inoperable T4 disease or supraclavicular metastasis after induction treatment

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

NCCKorea

Goyang-si, Gyeonggi-do, 411-794, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bin Hwangbo, MD. PhD

  Goyang, Gyeonggi-do, Korea, Republic of

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

KR (1)