Navigated EBUS and Functional Imaging in Lung Cancer
Primary Purpose
Bronchial Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
navigated bronchoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Bronchial Neoplasms focused on measuring Bronchoscopy, Bronchoscopes
Eligibility Criteria
Inclusion Criteria:
- referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
- informed consent
Exclusion Criteria:
- pregnancy
Sites / Locations
- Department of Thoracic Medicine, St Olavs HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
navigated bronchoscopy
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
duration of procedure
time from first entry of endoscope through vocal cords to final withdrawal of endoscope
patient reported satisfaction
enquiry on patients´ own experience 2 hours after end of navigated bronchoscopy/EBUS procedure
adverse events
procedure related adverse events or unexpected incidents registrated
Operator reported satisfaction
Enquiry on main operator´s experience immediately after end of navigated bronchoscopy/EBUS procedure
Diagnostic yield
Diagnostic success per TBNA sample defined as >40 lymphocytes/high power field as reported by rapid onsite cytologist
Full Information
NCT ID
NCT02745002
First Posted
April 13, 2016
Last Updated
April 11, 2023
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, SINTEF Health Research
1. Study Identification
Unique Protocol Identification Number
NCT02745002
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2016 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, SINTEF Health Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Neoplasms
Keywords
Bronchoscopy, Bronchoscopes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
navigated bronchoscopy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
navigated bronchoscopy
Other Intervention Name(s)
position tracked bronchoscope, navigated endobronchial ultrasound (EBUS)
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
duration of procedure
Description
time from first entry of endoscope through vocal cords to final withdrawal of endoscope
Time Frame
48 hours
Title
patient reported satisfaction
Description
enquiry on patients´ own experience 2 hours after end of navigated bronchoscopy/EBUS procedure
Time Frame
2 hours
Title
adverse events
Description
procedure related adverse events or unexpected incidents registrated
Time Frame
48 hours
Title
Operator reported satisfaction
Description
Enquiry on main operator´s experience immediately after end of navigated bronchoscopy/EBUS procedure
Time Frame
48 hours
Title
Diagnostic yield
Description
Diagnostic success per TBNA sample defined as >40 lymphocytes/high power field as reported by rapid onsite cytologist
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
informed consent
Exclusion Criteria:
pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanne Sorger, md
Email
hanne.sorger@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Håkon Olav Leira, md phd
Email
hakon.o.leira@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toril A Nagelhus Hernes, prof
Organizational Affiliation
Department of Circulation and Imaging
Official's Role
Study Director
Facility Information:
Facility Name
Department of Thoracic Medicine, St Olavs Hospital
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Håkon Olav Leira, md phd
Email
hakon.o.leira@ntnu.no
First Name & Middle Initial & Last Name & Degree
Arne Kildahl-Andersen
Email
Arne.Kildahl-Andersen@stolav.no
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26615428
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.
Results Reference
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Navigated EBUS and Functional Imaging in Lung Cancer
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