Automatic CT-to-patient Registration During Navigated Bronchoscopy and EBUS

Bronchial Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493023
• Other study ID #: 2010/3385
• Status: Completed
• Phase: N/A
• First received: July 1, 2015
• Last updated: March 29, 2016
• Start date: October 2011
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• referred to thoracic department St Olavs Hospital due to suspicion of lung cancer

• informed consent

Exclusion Criteria:

• pregnancy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bronchial Neoplasms

Intervention

Device:
• navigated bronchoscopy

Locations

Country	Name	City	State
Norway	Department of Thoracic Medicine, St Olavs Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology, SINTEF Health Research

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Sorger H, Hofstad EF, Amundsen T, Langø T, Leira HO. A novel platform for electromagnetic navigated ultrasound bronchoscopy (EBUS). Int J Comput Assist Radiol Surg. 2015 Nov 28. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endoscope position (measured in millimetres from origo in the x, y and z-plane) in 3 dimensional maps from preoperative CT 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	No
Secondary	duration of procedure	time from first entry of endoscope through vocal cords to final withdrawal of endoscope	48 hours	No
Secondary	patient reported satisfaction	enquiry on patients´own experience 2 hours after end of navigated bronchoscopy/EBUS procedure	48 hours	No
Secondary	adverse events	procedure related adverse events or unexpected incidents registrated	48 hours	No