Navigated EBUS and Functional Imaging in Lung Cancer

Study Overview
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Brief Summary
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Electromagnetic navigation systems have proved feasible for precise intraoperative guiding during videobronchoscopy and endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA), based on maps made of preoperative CT images. PET--CT, PET--MRI and fMRI can point out malignant lesions. When fused into a research navigation system, functional imaging can add information of optimal sampling points in lung cancer staging. Correct image registration is then fundamental. This study is a build--on to NCT02493023, assessing the position and image registration accuracy and clinical feasibility of a multimodal image guiding system in patients referred for lung cancer staging by EBUS--TBNA.

Detailed Description
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A research navigation platform displays the intraoperative position of the endoscope inside the airways, and shows its position in 3D maps made from the patients' own preoperative images (PET-- CT, PET--MRI or fMRI). Images are acquired ahead of study inclusion. The navigation system acquires position data, first from a videobronchoscope, then from an EBUS--scope (same sort of output data acquired from both endoscopes) equipped with a position sensor for electromagnetic tracking. From intraoperative position data, the accuracy of the image--to--patient registration (for CT, PET--CT, PET--MRI and fMRI) and the navigation system accuracy are calculated. Electromagnetic navigation fused with available image modalities can be used to navigate directly and precisely to the area with highest suspicion of malignancy. Multimodal image guiding systems with functional imaging may thereby lead to improvements in endoscopic lung cancer staging, f. i. in diagnostic yield, procedure time and safety.

Official Title
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Assessment of a Novel, Fast and Automatic CT-to-patient Registration Method During Navigated Bronchoscopy and Endobronchial Ultrasound Bronchoscopy (EBUS)

Conditions
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Bronchial Neoplasms

Intervention / Treatment
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* Device: navigated bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: referred to thoracic department St Olavs Hospital due to suspicion of lung cancer informed consent Exclusion Criteria: pregnancy

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: navigated bronchoscopy<br> | Device: navigated bronchoscopy<br> <br> * Other names: navigated endobronchial ultrasound (EBUS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscope position (measured in millimetres from origo in the x, y and z-plane) in 3 dimensional maps from preoperative CT, PET-CT, PET-MRI or fMRI images | intraoperative positional data of bronchoscope or endobronchial ultrasound scope (EBUS) measured and stored in navigation system software, used for registration and navigation system accuracy calculations | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of procedure | time from first entry of endoscope through vocal cords to final withdrawal of endoscope | 48 hours | 
| patient reported satisfaction | enquiry on patients´ own experience 2 hours after end of navigated bronchoscopy/EBUS procedure | 2 hours | 
| adverse events | procedure related adverse events or unexpected incidents registrated | 48 hours | 
| Operator reported satisfaction | Enquiry on main operator´s experience immediately after end of navigated bronchoscopy/EBUS procedure | 48 hours | 
| Diagnostic yield | Diagnostic success per TBNA sample defined as >40 lymphocytes/high power field as reported by rapid onsite cytologist | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchoscopy, Bronchoscopes