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CT-PET Virtual Bronchoscopy Guided Transbronchial Needle Aspiration for Mediastinal Lymph Node Staging in Suspected Lung Cancer

18 Years
Not Enrolling
Lung Cancer

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Trial Information

CT-PET Virtual Bronchoscopy Guided Transbronchial Needle Aspiration for Mediastinal Lymph Node Staging in Suspected Lung Cancer

Accurate staging of mediastinal lymph nodes (MLNs) in patients with lung carcinoma (LC) is
paramount as the N stage largely determines treatment strategy, prognosis and outcome.
Surgical staging such as mediastinoscopy is considered the gold standard. A less invasive
alternative is transbronchial needle aspiration (TBNA). This technique is limited however by
moderate and operator dependent accuracy. Recently less invasive strategies such as
esophageal ultrasound guided fine needle aspiration (EUS-FNA) and endobronchial ultrasound
guided TBNA (EBUS-TBNA) were introduced. These strategies have largely complemented TBNA and
surgical staging, with high accuracy and low morbidity. Disadvantages compared to TBNA
however are required specific expertise, higher equipment and maintenance costs, the need
for more assisting personnel and the need for sedation. Advances in computer generated image
processing based on available CT and PET images enable (quasi) real-time virtual
bronchoscopy that can assist minimal invasive surgical performance including bronchoscopy.
Optimizing the traditional TBNA procedure with these modern imaging techniques might be
equally accurate and more cost effective.

Inclusion Criteria:

- Age > 18 years

- Proven or suspected lung cancer, base on clinical picture and/or CT-PET findings

- Suspected involvement of mediastinal lymph nodes on CT-PET scan

- Written informed consent

Exclusion Criteria:

- None

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Feasibility of VB in determining N2/N3 mediastinal lymph nodes

Outcome Description:

Feasibility of virtual bronchoscopy in showing the presence or abscense of N2/N3 mediastinal lymph node (MLN) metastasis with accuracy of 0.6 in puncturing MLN > 15 mm (CT images) and accuracy of 0.8 for MLN < 15 mm in the second phase of the study.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Sayed Hashemi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

VU University Medical Center


Netherlands: Medical Ethics Review Committee (METC)

Study ID:




Start Date:

April 2010

Completion Date:

May 2011

Related Keywords:

  • Lung Cancer
  • lung cancer
  • mediastinal lymph nodes
  • TBNA
  • staging lung cancer
  • Lung Neoplasms