Bronchial NeoplasmsNCT02745002
Navigated EBUS and Functional Imaging in Lung Cancer
A study testing navigated bronchoscopy in people with Bronchial Neoplasms, run by St. Olavs Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Neoplasms
- What is being tested?
- navigated bronchoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2016to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
- informed consent
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchial Neoplasms
- Being tested
- navigated bronchoscopy
- Keywords
- Bronchoscopy, Bronchoscopes
- Medical subject headings
- Bronchial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navigated bronchoscopyDevice
Also called position tracked bronchoscope, navigated endobronchial ultrasound (EBUS)
| Study group | Role | What they receive |
|---|---|---|
| navigated bronchoscopy | Experimental | Not described Receives: Device: navigated bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (5)
duration of procedure
time from first entry of endoscope through vocal cords to final withdrawal of endoscope
Measured: 48 hours
patient reported satisfaction
enquiry on patients´ own experience 2 hours after end of navigated bronchoscopy/EBUS procedure
Measured: 2 hours
adverse events
procedure related adverse events or unexpected incidents registrated
Measured: 48 hours
Operator reported satisfaction
Enquiry on main operator´s experience immediately after end of navigated bronchoscopy/EBUS procedure
Measured: 48 hours
Diagnostic yield
Diagnostic success per TBNA sample defined as >40 lymphocytes/high power field as reported by rapid onsite cytologist
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchial NeoplasmsStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, SINTEF Health Research
- Responsible party
- Sponsor
- Investigators
- Toril A Nagelhus Hernes, prof, Study director, Department of Circulation and Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745002
- Sponsor's protocol ID
- 2015/1913
- Status last verified
- Jan 2024
- First submitted
- 13 Apr 2016
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26615428
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Novel, Fast and Automatic CT-to-patient Registration Method During Navigated Bronchoscopy and Endobronchial Ultrasound Bronchoscopy (EBUS)
- ClinicalTrials.gov ID
- NCT02745002
- Acronym / sponsor ID
- 2015/1913
- Conditions
- Bronchial Neoplasms
- Keywords
- Bronchoscopy, Bronchoscopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, SINTEF Health Research
- Study start
- Apr 2016 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| navigated bronchoscopy | Experimental | Device: navigated bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
- informed consent
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| navigated bronchoscopyAlso: position tracked bronchoscope, navigated endobronchial ultrasound (EBUS) | Device | navigated bronchoscopy |
Primary outcome
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
5 secondary outcomes
duration of procedure
Time frame: 48 hours
patient reported satisfaction
Time frame: 2 hours
adverse events
Time frame: 48 hours
Operator reported satisfaction
Time frame: 48 hours
Diagnostic yield
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 26615428Sorger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toril A Nagelhus Hernes, prof study director
Department of Circulation and Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing navigated bronchoscopy in people with Bronchial Neoplasms, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02745002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.