Virtual Bronchoscopy Transbronchial Needle Aspiration(TBNA): a Proof of Concept Study

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to determine wether CT-PET virtual bronchoscopy guided transbronchial needle aspiration is suitable for the investigation of mediastinal lymph nodes which is needed for correct staging of lung cancer.

Condition or disease	Intervention/treatment
Lung Cancer	Other: Virtual Bronchoscopy Navigation

Detailed Description:

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	80 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	CT-PET Virtual Bronchoscopy Guided Transbronchial Needle Aspiration for Mediastinal Lymph Node Staging in Suspected Lung Cancer
Study Start Date :	April 2010
Actual Primary Completion Date :	May 2011
Actual Study Completion Date :	May 2011

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Suspected mediastianl lymph nodes; Patients with (suspected) lung cancer requiring MLN staging after CT-PET during routine work-up according to existing staging guidelines.	Other: Virtual Bronchoscopy Navigation; Use of dedicated virtual bronchoscopy navigation software using 4D CT-PET scan spacial data.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Feasibility of VB in determining N2/N3 mediastinal lymph nodes [ Time Frame: 1 year ]
   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.

Secondary Outcome Measures :

1. Duration of the session within the optimal time window of local anesthesia using lidocaine 1%; comparable to standard routine bronchoscopic procedure on an outpatient basis, i.e. not exceeding 30 minutes. [ Time Frame: 1 year ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with suspected lung cancer requiring mediastinal lymph node staging after CT-PET scan during routine work-up according to local guidelines.

Criteria

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:

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1081 HV

Sponsors and Collaborators

VU University Medical Center

Philips Healthcare

Investigators

Study Chair:	Sayed Hashemi, MD	VU University Medical Center
Study Chair:	Hans Daniels, MD	VU University Medical Center
Study Chair:	Emiel Comans, PhD	VU University Medical Center
Study Chair:	Otto Hoekstra, PhD	VU University Medical Center
Study Chair:	Piet Postmus, PhD	VU University Medical Center
Principal Investigator:	Tom Sutedja, PhD	VU University Medical Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	T.G. Sutedja, MD, PhD, VU University Medical Center
ClinicalTrials.gov Identifier:	NCT01077492 History of Changes
Other Study ID Numbers:	09/327
First Posted:	March 1, 2010
Last Update Posted:	November 2, 2012
Last Verified:	February 2010

Keywords provided by VU University Medical Center:

lung cancer; mediastinal lymph nodes; TBNA; staging lung cancer

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site	Neoplasms; Lung Diseases; Respiratory Tract Diseases