Navigational Bronchoscopy and Transthoracic Needle Biopsy for the Diagnosis of Peripheral Pulmonary Nodules: A Safety and Feasibility Pilot

Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy

Sponsors

Lead sponsor: Johns Hopkins University

Collaborator: Veran Medical Technologies

Source Johns Hopkins University
Brief Summary

The goal of this study is to evaluate the feasibility and safety of navigation guided virtual transthoracic needle biopsy combined with navigational bronchoscopy for the diagnosis of peripheral pulmonary nodules (PPN).

Detailed Description

Accessing peripheral pulmonary nodules is problematic because they are often not visible endobronchially, not large enough to be visualized by x-ray fluoroscopy for transbronchial biopsy (TBBx), and/or do not lie within an accessible airway. In this study, investigators hope to evaluate new technologies to aid in PPN biopsy using navigation bronchoscopy (NB) combined with navigation transthoracic needle aspiration (N-TTNA) sampling of a PPN.

Patients meeting inclusion criteria who consent will undergo a convex Endobronchial Ultrasound (EBUS) bronchoscopy for evaluation and sampling of the mediastinum and hilum. Following this, NB will be performed with an ultrathin bronchoscope (4mm outer diameter with a 2 mm working channel) with R-EBUS and fluoroscopy. If the lesion is localized by NB and/or radial EBUS in conjunction with NB, TBBX will be taken. At the conclusion of TBBX sampling, a fluoroscopic evaluation to assess for the presence of pneumothorax will be performed and if one is present, appropriate clinical measures will be taken at the discretion of the treating team (tube thoracostomy, observation, etc.) and no further sampling techniques will be utilized. If the lesion was not able to be localized via NB and/or the physician feels insufficient sample was acquired for diagnosis and there is no evidence of pneumothorax, the patient will undergo N-TTNA at the same PPN during the same procedure time. It is envisioned that between 8-12 patients will require a N-TTNA to complete diagnosis.

Overall Status Completed
Start Date September 2013
Completion Date August 2015
Primary Completion Date August 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Feasibility Immediately following procedure
Feasibility Immediately following procedure
Feasibility Immediately following procedure
Incidence of Pneumothorax Immediately after procedure
Incidence of Pneumothorax Immediately after procedure
Incidence of Pneumothorax Immediately after procedure
Secondary Outcome
Measure Time Frame
Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone Approximately 1 week upon receipt of pathology report
Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB Approximately 1 week upon receipt of pathology report
Enrollment 24
Condition
Intervention

Intervention type: Device

Intervention name: Navigation guided bronchoscopy

Description: Navigation guided transthoracic needle aspiration (N-TTNA) and navigation guided bronchoscopy (NB); guidance system is by Veran Medical Technologies, Inc.

Arm group label: Assessing peripheral pulmonary nodules

Eligibility

Criteria:

Inclusion criteria:

- Target patient population: Patients with a peripheral pulmonary nodule as identified on CT chest ≤3cm from the pleura will be recruited. A PPN will be defined as a lesion >10mm and <3cm in diameter surrounded by lung parenchyma on CT chest. The decision for biopsy of the PPN will be made by the treating physician and agreed upon by the patient.

- Participants must be at least 18 years old or older

- No bleeding disorders

- Provide informed consent.

Exclusion criteria

- less than 18 years

- lack of fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure

- inability to give informed consent

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Lonny Yarmus, DO Principal Investigator Johns Hopkins University
Location
facility
Johns Hopkins University
Location Countries

United States

Verification Date

March 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Assessing peripheral pulmonary nodules

Arm group type: Experimental

Description: To evaluate the feasibility and safety of a procedure path including convex Endobronchial Ultrasound (EBUS) lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov