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)
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
April 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 10, 2024
January 1, 2024
7.8 years
April 13, 2016
January 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
duration of procedure
48 hours
patient reported satisfaction
2 hours
adverse events
48 hours
Operator reported satisfaction
48 hours
Diagnostic yield
48 hours
Study Arms (1)
navigated bronchoscopy
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
- informed consent
You may not qualify if:
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Olavs Hospitallead
- Norwegian University of Science and Technologycollaborator
- SINTEF Health Researchcollaborator
Study Sites (1)
Department of Thoracic Medicine, St Olavs Hospital
Trondheim, Norway
Related 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.
PMID: 26615428BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Toril A Nagelhus Hernes, prof
Department of Circulation and Imaging
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2016
First Posted
April 20, 2016
Study Start
April 1, 2016
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
January 10, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share