Cone Beam CT Guided Electromagnetic Navigational Bronchoscopy (CBCTENB)

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.

Study Overview

• Status: Completed
• Conditions: Lung Mass; Lung Nodule; Lesion of the Lung
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Columbus, Indiana, United States, 47201
      • Columbus Regional Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Patients with lung nodule
• Patients with lung mass
• Patients undergoing undergoing electromagnetic navigation bronchoscopy for biopsy.

Exclusion Criteria:

• Patients less than 18 years of age
• Patients unable to complete the electromagnetic navigational bronchoscopy procedure.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity for malignancy	Percentage of malignant lesions accurately diagnosed on biopsy	1 year Follow up. Prelim results to be reviewed at 3 months
Diagnostic Yield	Percentage of correct underlying diagnosis	1 year Follow up. Prelim results to be reviewed at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Complications	Pneumothorax or Bleeding	1 year Follow up. Prelim results to be reviewed at 3 months
Procedure Time	Intra-Operative time	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.	1 year Follow up. Prelim results to be reviewed at 3 months

Collaborators and Investigators

• Sponsor: Columbus Regional Health
• Investigators: Principal Investigator: Deepankar Sharma, MD, Columbus Regional Health

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): November 2, 2021

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Electromagnetic Navigation Bronchoscopy; Cone Beam CT; Lung Lesion; Lung Mass; Lung Nodule; CT Augmented Fluoroscopy; EMN
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No