Lung NoduleCBCTENBNCT04194333
Cone Beam CT Guided Electromagnetic Navigational Bronchoscopy
An observational study of Lung Nodule and Lung Mass, run by Columbus Regional Health at 1 site in United States.
Trial summary
Electromagnetic navigation bronchoscopy (ENB) is used to access peripheral and central parenchymal lung lesions via endobronchial and transbronchial approach. Traditionally ENB is done under fluoroscopic guidance using C-arm but with development of Cone Beam CT and 3D reconstruction technology, fluoroscopy can be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Nodule, Lung Mass, Lesion of the Lung
- What is being tested?
- Cone Beam CT with Embo Guide to creat 3D Overlay and CT Augmented Fluoroscopy to guide Electromagnetic Navigational Bronchoscopy instead of Standard Fluroscopic guidance using the C-Arm
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 2 Nov 2021
- Phase
- Observational
- 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
Study population: Patients with lung nodule, mass or lesion undergoing electromagnetic navigation bronchoscopy for biopsy. Majority of the patients are smokers. Some of the patients are found to have the lung nodule, mass or lesion incidentally or on the low-dose CT for lung cancer screening.
Who may be able to join
- Patients with lung nodule
- Patients with lung mass
- Patients undergoing undergoing electromagnetic navigation bronchoscopy for biopsy.
Who cannot join
- Patients less than 18 years of age
- Patients unable to complete the electromagnetic navigational bronchoscopy procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Diagnostic Yield of Electromagnetic Navigational Bronchoscopy Guided With Real Time Cone Beam Computer Tomography With Standard Fluoroscopy Guidance for Peripheral and Central Lung Lesions
Electromagnetic navigation bronchoscopy (ENB) is used to access peripheral and central parenchymal lung lesions via endobronchial and transbronchial approach. Traditionally ENB is done under fluoroscopic guidance using C-arm but with development of Cone Beam CT and 3D reconstruction technology, fluoroscopy can be enhanced to much higher resolution and can also provide real time 3D augmentation of the lesion. It also enables the user to obtain a CT of the Chest to confirm the real time location of the lesion and the bronchoscopic biopsy catheter and instruments. This is thought to improve the yield and sensitivity of ENB guided Biopsy of the lung nodules and masses but has not been proven in a prospective trial. With my study, I want to examine the effect of Cone Beam CT with 3D reconstruction on the diagnostic yield and sensitivity of Electromagnetic Navigational Bronchoscopic biopsy of the lung lesions.
Read the detailed description
Electromagnetic navigation bronchoscopy has been used for more than a decade to access peripheral and central parenchymal lung lesions bronchoscopically. Traditionally standard fluoroscopy using C-arm is used to confirm the location and guide the biopsy instruments under real-time guidance. With availability of Cone Beam CT, fluoroscopic images of much higher quality and resolution can be obtained intra-operatively. It also enables the bronchoscopist to obtain intraoperative CT images and confirm the exact location of the lesion and the Bronchoscopic biopsy catheter or the biopsy instruments.
At my institution, lung nodules/masses requiring ENB have been approached using Medtronic Super-Dimension Version 7 Electromagnetic Navigational Bronchoscopy system. All the procedures are done under fluroscopic guidance using a regular C-Arm. All the lesions are confirmed using peripheral Endobronchial Ultrasound (EBUS). Once the appropriate location is reached, biopsy is obtained using FNA (18G or 21G), Single or Triple needle brush, Transbronchial forceps and Bronchoalveolar lavage.
A pathologist is present on site for all the cases to review the slides and assist in diagnosis. All the cases are done under general anesthesia through endotracheal tube.
Also, all the ENB procedures have been performed by one Interventional Pulmonologist since August 2017.
For the interventional arm, all the aspects will remain the same except that the cases are done in Hybrid OR instead of Endoscopy. All the patients are completely paralyzed intra-operatively. Also, instead of a standard C-Arm providing 2D fluoroscopic guidance, a Philips Azurion 7 C20 FlexMove system with Emboguide, 3D Segmentaion and Overlay tools is being used. This enables the bronchoscopist to obtain a CT scan of the chest and also segment out the lesion(s) of interest and to overlap the 3-D image of the lesion on live fluoroscopy in all 3 dimensions.
During the ENB procedures, at least 1 full Xpert CT is going to be obtained, mostly after completing the airway registration and ENB guided approach the lesion. Once the extended working channel and the locatable guide is advanced to the lesion using ENB guidance, the catheter is locked and scope held in place. The patient is maintained in inspiratory breath hold and Cone Beam Ct is used to obtain the Xpert CT that shows the lesion and surrounding lungs, chest and mediastinal structures in the surrounding area of the chest.
This is then used to analyze the location of the lesion and the lesion of the extended working channel, locatable guide and the biopsy instruments in relation to the lesion. The lesion is then segmented and EmboGuide+Overlay feature is used to project a 3D view of the lesion on the live fluoroscopic images in all three axis. This also allows the bronchoscopist to obtain Anterior-posterior, Lateral and oblique views at various angles while maintaining the 3D overlap.
Additional CT scans might be obtained intra-operatively if needed to guide the biopsy catheter appropriately towards the lesion. Due to the live nature of the Cone Beam CT, it is much more capable of providing accurate guidance regarding the location of the lesion and the biopsy instruments. hence, in case of any discrepancy, information provided by Cone Beam CT is considered more reliable and used with higher confidence.
Rest of the steps involved in procedure are similar between the control and the interventional arm including the surgeon, type of bronchoscopes, type of electromagnetic navigational system, use of peripheral Endobronchial Ultrasound and availability of on-site pathologist. The biopsy instruments used are also the same including transbronchial needle for FNA, Single or triple needle brush and transbronchial forceps. Bronchoalveolar lavage is also obtained at the end via extended working channel.
All the patients undergoing biopsy of the peripheral/central lung lesions using ENB also undergo Convex EBUS guided mediastinal surveillance and EBUS-TBFNA of any Lymph Node that appears to be greater than 5 mm on EBUS exam.
My study aims to study the effect of using Cone Beam CT with segmentation, 3-D overlay and CT augmented fluoroscopy on sensitivity and diagnostic yield of electromagnetic navigation bronchoscopy for diagnosis of peripheral and central lung lesions including lung nodules and masses which could not be directly accessed using just white light bronchoscope.
- Conditions
- Lung Nodule, Lung Mass, Lesion of the Lung
- Being tested
- Cone Beam CT with Embo Guide to creat 3D Overlay and CT Augmented Fluoroscopy to guide Electromagnetic Navigational Bronchoscopy instead of Standard Fluroscopic guidance using the C-Arm
- Keywords
- Lung Nodule, Lung Mass, Lung Lesion, Cone Beam CT, CT Augmented Fluoroscopy, EMN, Electromagnetic Navigation Bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam CT with Embo Guide to creat 3D Overlay and CT Augmented Fluoroscopy to guide Electromagnetic Navigational Bronchoscopy instead of Standard Fluroscopic guidance using the C-ArmProcedure or surgery
Instead of the standard fluoroscopy using the C-arm, the intervention will undergo electromagnetic navigation guided bronchoscopy while using Cone Beam CT with Embo Guide to creat 3D Overlay and CT Augmented Fluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Standard Fluoroscopy Guided EMN | Patient is undergoing electromagnetic navigation bronchoscopy using Medtronic super D version 7 EMN system, peripheral endobronchial ultrasound and standard fluoroscopy using the C-arm under general anesthesia. | |
| Cone Beam CT Guided EMN | Patient is undergoing electromagnetic navigation bronchoscopy using Medtronic super D version 7 EMN system, peripheral endobronchial ultrasound and Cone Beam CT Guidance using the Philips Azurion 7 C20 FlexMove with Embo Guide and Overlay software to create CT Augmented Fluoroscopy under general anesthesia. Receives: Procedure: Cone Beam CT with Embo Guide to creat 3D Overlay and CT Augmented Fluoroscopy to guide Electromagnetic Navigational Bronchoscopy instead of Standard Fluroscopic guidance using the C-Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for malignancy
Percentage of malignant lesions accurately diagnosed on biopsy
Measured: 1 year Follow up. Prelim results to be reviewed at 3 months
Diagnostic Yield
Percentage of correct underlying diagnosis
Measured: 1 year Follow up. Prelim results to be reviewed at 3 months
Secondary outcomes (3)
Procedural Complications
Pneumothorax or Bleeding
Measured: 1 year Follow up. Prelim results to be reviewed at 3 months
Procedure Time
Intra-Operative time
Measured: 1 year Follow up. Prelim results to be reviewed at 3 months
Radiation Exposure
Will have a record of radiation dose for the Cone Beam CT cases but not for the C-Arm cases. Will compare the radiation exposure in the Intervention arm to the average reported radiation exposure in literature.
Measured: 1 year Follow up. Prelim results to be reviewed at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Aug 2017
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NoduleStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbus Regional Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepankar Sharma, Columbus Regional Health
- Investigators
- Deepankar Sharma, MD, Principal investigator, Columbus Regional Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194333
- Sponsor's protocol ID
- 001
- Acronym
- CBCTENB
- Status last verified
- Jul 2022
- First submitted
- 9 Dec 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Diagnostic Yield of Electromagnetic Navigational Bronchoscopy Guided With Real Time Cone Beam Computer Tomography With Standard Fluoroscopy Guidance for Peripheral and Central Lung Lesions
- ClinicalTrials.gov ID
- NCT04194333
- Acronym / sponsor ID
- CBCTENB / 001
- Conditions
- Lung Nodule, Lung Mass, Lesion of the Lung
- Keywords
- Lung Nodule, Lung Mass, Lung Lesion, Cone Beam CT, CT Augmented Fluoroscopy, EMN, Electromagnetic Navigation Bronchoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Columbus Regional HealthUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 11 Dec 2019 (actual)
- 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 bronchoscopy (ENB) is used to access peripheral and central parenchymal lung lesions via endobronchial and transbronchial approach. Traditionally ENB is done under fluoroscopic guidance using C-arm but with development of Cone Beam CT and 3D reconstruction technology, fluoroscopy can be enhanced to much higher resolution and can also provide real time 3D augmentation of the lesion. It also enables the user to obtain a CT of the Chest to confirm the real time location of the lesion and the bronchoscopic biopsy catheter and instruments. This is thought to improve the yield and sensitivity of ENB guided Biopsy of the lung nodules and masses but has not been proven in a prospective trial. With my study, I want to examine the effect of Cone Beam CT with 3D reconstruction on the diagnostic yield and sensitivity of Electromagnetic Navigational Bronchoscopic biopsy of the lung lesions.
Detailed description
Electromagnetic navigation bronchoscopy has been used for more than a decade to access peripheral and central parenchymal lung lesions bronchoscopically. Traditionally standard fluoroscopy using C-arm is used to confirm the location and guide the biopsy instruments under real-time guidance. With availability of Cone Beam CT, fluoroscopic images of much higher quality and resolution can be obtained intra-operatively. It also enables the bronchoscopist to obtain intraoperative CT images and confirm the exact location of the lesion and the Bronchoscopic biopsy catheter or the biopsy instruments.
At my institution, lung nodules/masses requiring ENB have been approached using Medtronic Super-Dimension Version 7 Electromagnetic Navigational Bronchoscopy system. All the procedures are done under fluroscopic guidance using a regular C-Arm. All the lesions are confirmed using peripheral Endobronchial Ultrasound (EBUS). Once the appropriate location is reached, biopsy is obtained using FNA (18G or 21G), Single or Triple needle brush, Transbronchial forceps and Bronchoalveolar lavage.
A pathologist is present on site for all the cases to review the slides and assist in diagnosis. All the cases are done under general anesthesia through endotracheal tube.
Also, all the ENB procedures have been performed by one Interventional Pulmonologist since August 2017.
For the interventional arm, all the aspects will remain the same except that the cases are done in Hybrid OR instead of Endoscopy. All the patients are completely paralyzed intra-operatively. Also, instead of a standard C-Arm providing 2D fluoroscopic guidance, a Philips Azurion 7 C20 FlexMove system with Emboguide, 3D Segmentaion and Overlay tools is being used. This enables the bronchoscopist to obtain a CT scan of the chest and also segment out the lesion(s) of interest and to overlap the 3-D image of the lesion on live fluoroscopy in all 3 dimensions.
During the ENB procedures, at least 1 full Xpert CT is going to be obtained, mostly after completing the airway registration and ENB guided approach the lesion. Once the extended working channel and the locatable guide is advanced to the lesion using ENB guidance, the catheter is locked and scope held in place. The patient is maintained in inspiratory breath hold and Cone Beam Ct is used to obtain the Xpert CT that shows the lesion and surrounding lungs, chest and mediastinal structures in the surrounding area of the chest.
This is then used to analyze the location of the lesion and the lesion of the extended working channel, locatable guide and the biopsy instruments in relation to the lesion. The lesion is then segmented and EmboGuide+Overlay feature is used to project a 3D view of the lesion on the live fluoroscopic images in all three axis. This also allows the bronchoscopist to obtain Anterior-posterior, Lateral and oblique views at various angles while maintaining the 3D overlap.
Additional CT scans might be obtained intra-operatively if needed to guide the biopsy catheter appropriately towards the lesion. Due to the live nature of the Cone Beam CT, it is much more capable of providing accurate guidance regarding the location of the lesion and the biopsy instruments. hence, in case of any discrepancy, information provided by Cone Beam CT is considered more reliable and used with higher confidence.
Rest of the steps involved in procedure are similar between the control and the interventional arm including the surgeon, type of bronchoscopes, type of electromagnetic navigational system, use of peripheral Endobronchial Ultrasound and availability of on-site pathologist. The biopsy instruments used are also the same including transbronchial needle for FNA, Single or triple needle brush and transbronchial forceps. Bronchoalveolar lavage is also obtained at the end via extended working channel.
All the patients undergoing biopsy of the peripheral/central lung lesions using ENB also undergo Convex EBUS guided mediastinal surveillance and EBUS-TBFNA of any Lymph Node that appears to be greater than 5 mm on EBUS exam.
My study aims to study the effect of using Cone Beam CT with segmentation, 3-D overlay and CT augmented fluoroscopy on sensitivity and diagnostic yield of electromagnetic navigation bronchoscopy for diagnosis of peripheral and central lung lesions including lung nodules and masses which could not be directly accessed using just white light bronchoscope.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Fluoroscopy Guided EMN | – | –Patient is undergoing electromagnetic navigation bronchoscopy using Medtronic super D version 7 EMN system, peripheral endobronchial ultrasound and standard fluoroscopy using the C-arm under general anesthesia. |
| Cone Beam CT Guided EMN | – | Procedure: Cone Beam CT with Embo Guide to creat 3D Overlay and CT Augmented Fluoroscopy to guide Electromagnetic Navigational Bronchoscopy instead of Standard Fluroscopic guidance using the C-ArmPatient is undergoing electromagnetic navigation bronchoscopy using Medtronic super D version 7 EMN system, peripheral endobronchial ultrasound and Cone Beam CT Guidance using the Philips Azurion 7 C20 FlexMove with Embo Guide and Overlay software to create CT Augmented Fluoroscopy under general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung nodule, mass or lesion undergoing electromagnetic navigation bronchoscopy for biopsy. Majority of the patients are smokers. Some of the patients are found to have the lung nodule, mass or lesion incidentally or on the low-dose CT for lung cancer screening.
Key inclusion criteria (3 listed)
- Patients with lung nodule
- Patients with lung mass
- Patients undergoing undergoing electromagnetic navigation bronchoscopy for biopsy.
Key exclusion criteria (2 listed)
- Patients less than 18 years of age
- Patients unable to complete the electromagnetic navigational bronchoscopy procedure.
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 |
|---|---|---|
| Cone Beam CT with Embo Guide to creat 3D Overlay and CT Augmented Fluoroscopy to guide Electromagnetic Navigational Bronchoscopy instead of Standard Fluroscopic guidance using the C-ArmInstead of the standard fluoroscopy using the C-arm, the intervention will undergo electromagnetic navigation guided bronchoscopy while using Cone Beam CT with Embo Guide to creat 3D Overlay and CT Augmented Fluoroscopy. | Procedure or surgery | Cone Beam CT Guided EMN |
Primary outcome
Sensitivity for malignancy
Time frame: 1 year Follow up. Prelim results to be reviewed at 3 months
Percentage of malignant lesions accurately diagnosed on biopsy
Diagnostic Yield
Time frame: 1 year Follow up. Prelim results to be reviewed at 3 months
Percentage of correct underlying diagnosis
3 secondary outcomes
Procedural Complications
Time frame: 1 year Follow up. Prelim results to be reviewed at 3 months
Procedure Time
Time frame: 1 year Follow up. Prelim results to be reviewed at 3 months
Radiation Exposure
Time frame: 1 year Follow up. Prelim results to be reviewed at 3 months
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 21 Jul 2022.
- 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.
Deepankar Sharma, MD principal investigator
Columbus Regional Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Nodule and Lung Mass, run by Columbus Regional Health at 1 site in United States.
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 3 inclusion and 2 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 21 Jul 2022. 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 United States. 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?
Sensitivity for malignancy (time frame: 1 year Follow up. Prelim results to be reviewed at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2022.