- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02745002
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
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
-
-
-
Trondheim, Norway
- Department of Thoracic Medicine, St Olavs Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: navigated bronchoscopy
|
Other Names:
|
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
Time Frame: 48 hours
|
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 Frame: 48 hours
|
time from first entry of endoscope through vocal cords to final withdrawal of endoscope
|
48 hours
|
patient reported satisfaction
Time Frame: 2 hours
|
enquiry on patients´ own experience 2 hours after end of navigated bronchoscopy/EBUS procedure
|
2 hours
|
adverse events
Time Frame: 48 hours
|
procedure related adverse events or unexpected incidents registrated
|
48 hours
|
Operator reported satisfaction
Time Frame: 48 hours
|
Enquiry on main operator´s experience immediately after end of navigated bronchoscopy/EBUS procedure
|
48 hours
|
Diagnostic yield
Time Frame: 48 hours
|
Diagnostic success per TBNA sample defined as >40 lymphocytes/high power field as reported by rapid onsite cytologist
|
48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Toril A Nagelhus Hernes, prof, Department of Circulation and Imaging
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/1913
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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