Navigated EBUS and Functional Imaging in Lung Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchial Neoplasms
• Intervention / Treatment: Device: navigated bronchoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanne Sorger, md; Email: hanne.sorger@ntnu.no
• Study Contact Backup: Name: Håkon Olav Leira, md phd; Email: hakon.o.leira@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway
    • Department of Thoracic Medicine, St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: navigated bronchoscopy	Device: navigated bronchoscopy; Other Names: position tracked bronchoscope; navigated endobronchial ultrasound (EBUS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology; SINTEF Health Research
• Investigators: Study Director: Toril A Nagelhus Hernes, prof, Department of Circulation and Imaging

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimated): April 20, 2016

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Bronchoscopy; Bronchoscopes
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Bronchial Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Bronchial Neoplasms
• Other Study ID Numbers: 2015/1913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No