Cone Beam CT Guided Electromagnetic Navigational Bronchoscopy

NCT04194333 | Completed DMC

• 1 other identifier: 001
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Procedural Complications

  1 year Follow up. Prelim results to be reviewed at 3 months

• Procedure Time

  1 year Follow up. Prelim results to be reviewed at 3 months

• Radiation Exposure

  1 year Follow up. Prelim results to be reviewed at 3 months

Study Arms (2)

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

Interventions

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 PROCEDURE

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.

Cone Beam CT Guided EMN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbus Regional Health: lead

Study Sites (1)

Columbus Regional Health

Columbus, Indiana, 47201, United States

Location

Study Officials

• Deepankar Sharma, MD

  Columbus Regional Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Lung Institute and Section Chief, Pulmonary & Critical Care

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: August 1, 2017
• Primary Completion: November 2, 2021
• Study Completion: November 2, 2021
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)