Clinical trial NCT02745002: Navigated EBUS and Functional Imaging in Lung Cancer
Official title: Assessment of a Novel, Fast and Automatic CT-to-patient Registration Method During Navigated Bronchoscopy and Endobronchial Ultrasound Bronchoscopy (EBUS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchial Neoplasms
Keywords: Bronchoscopy
Bronchoscopes
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: SINTEF Health Research
First posted: 2016-04-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
* informed consent

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: 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
timeFrame: 48 hours
Secondary outcomes:
measure: duration of procedure
timeFrame: 48 hours
measure: patient reported satisfaction
timeFrame: 2 hours
measure: adverse events
timeFrame: 48 hours
measure: Operator reported satisfaction
timeFrame: 48 hours
measure: Diagnostic yield
timeFrame: 48 hours
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Thoracic Medicine, St Olavs Hospital
Study officials:
affiliation: Department of Circulation and Imaging
name: Toril A Nagelhus Hernes, prof
role: STUDY_DIRECTOR
References:
citation: Sorger H, Hofstad EF, Amundsen T, Lango T, Leira HO. A novel platform for electromagnetic navigated ultrasound bronchoscopy (EBUS). Int J Comput Assist Radiol Surg. 2016 Aug;11(8):1431-43. doi: 10.1007/s11548-015-1326-7. Epub 2015 Nov 28.