Navigated EBUS and Functional Imaging in Lung Cancer

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: NCT02745002
• Other study ID #: 2015/1913
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• 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

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