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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Virtual Bronchoscopy Navigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of VB in determining N2/N3 mediastinal lymph nodes | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, mediastinal lymph nodes, TBNA, staging lung cancer