Clinical trial NCT02493023: Automatic CT-to-patient Registration During Navigated Bronchoscopy and EBUS
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: 2015-07-09
Enrollment: 26
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: Bronchoscopic diagnosis and staging of lung cancer must be gentle and quick, and requires optimal sampling precision.Electromagnetic navigation systems are promising for intraoperative guiding based on maps made of preoperative CT images. Navigation accuracy depends largely on correct alignment of preoperative images to the patient´s position in space during endoscopy. In this study, the accuracy of a new fast and automatic image-to-patient registration method during the initial phase of bronchoscopy is assessed in patients referred for lung cancer investigation.

Detailed description: This is an accuracy study of a new automatic CT-to-patient registration technique for bronchoscopy and endobronchial ultrasound bronchoscopy (EBUS). An in-house research and development navigation platform displays the intraoperative position of the endoscope inside the airways, and shows its exact position in three-dimensional (3D) maps made from the patients' own preoperative CT images. The navigation system is used for acquiring position data from a bronchoscope or EBUS-scope (same sort of output data acquired from both endoscopes in this study) equipped with a position sensor for electromagnetic tracking. From intraoperative position data, the accuracy of the image-to-patient registration and the navigation system accuracy can be calculated. When targeting a certain lymph node or tumor for sampling, the pulmonologist can use electromagnetic navigation combined with preoperative CT images to navigate directly, precisely and accurately to the area of interest. Functional systems for navigated bronchoscopy and EBUS may therefore lead to considerable improvements in lung cancer diagnosis and mediastinal staging.

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 images
timeFrame: 48 hours
Secondary outcomes:
measure: duration of procedure
timeFrame: 48 hours
measure: patient reported satisfaction
timeFrame: 48 hours
measure: adverse events
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.