Navigated EBUS and Functional Imaging in Lung Cancer
- Conditions
- Bronchial Neoplasms
- Interventions
- Device: navigated bronchoscopy
- Registration Number
- NCT02745002
- Lead Sponsor
- St. Olavs Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
- informed consent
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description navigated bronchoscopy navigated bronchoscopy -
- Primary Outcome Measures
Name Time Method 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 48 hours 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
- Secondary Outcome Measures
Name Time Method duration of procedure 48 hours time from first entry of endoscope through vocal cords to final withdrawal of endoscope
patient reported satisfaction 2 hours enquiry on patients´ own experience 2 hours after end of navigated bronchoscopy/EBUS procedure
adverse events 48 hours procedure related adverse events or unexpected incidents registrated
Operator reported satisfaction 48 hours Enquiry on main operator´s experience immediately after end of navigated bronchoscopy/EBUS procedure
Diagnostic yield 48 hours Diagnostic success per TBNA sample defined as \>40 lymphocytes/high power field as reported by rapid onsite cytologist
Trial Locations
- Locations (1)
Department of Thoracic Medicine, St Olavs Hospital
🇳🇴Trondheim, Norway