Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02109458
• Collaborator: Veran Medical Technologies (Industry)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Peripheral Pulmonary Nodules	Device: Navigation guided bronchoscopy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Navigational Bronchoscopy and Transthoracic Needle Biopsy for the Diagnosis of Peripheral Pulmonary Nodules: A Safety and Feasibility Pilot
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Assessing peripheral pulmonary nodules 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).	Device: Navigation guided bronchoscopy; Navigation guided transthoracic needle aspiration (N-TTNA) and navigation guided bronchoscopy (NB); guidance system is by Veran Medical Technologies, Inc.

Outcome Measures

Primary Outcome Measures

1. Feasibility [Immediately following procedure]

   Feasibility assessed by number of participants with successful completion of biopsy (i.e. a biopsy was able to be obtained to collect a tissue sample)

2. Incidence of Pneumothorax [Immediately after procedure]

   Presence of pneumothorax assessed in participants with successful completion of biopsy.

Secondary Outcome Measures

1. 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 Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) alone was defined by participants having benign or malignant pathology.

2. Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB [Approximately 1 week upon receipt of pathology report]

   Positive diagnostic yield of bronchoscopic biopsy of ETTNA + EBUS + NB was defined by participants having benign or malignant pathology.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University
• Veran Medical Technologies

Investigators

• Principal Investigator: Lonny Yarmus, DO, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02109458
• Other Study ID Numbers: NA_00086035
• First Posted: Apr 10, 2014
• Last Update Posted: Apr 24, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Johns Hopkins University: Lung nodule biopsy
• Additional relevant MeSH terms: Multiple Pulmonary Nodules

Study Results

Participant Flow

Arm/Group Title	Assessing Peripheral Pulmonary Nodules
Arm/Group 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). Navigation guided bronchoscopy
Period Title: Overall Study
STARTED	24
COMPLETED	24
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Assessing Peripheral Pulmonary Nodules
Arm/Group Description	To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
Overall Participants	24
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 33.3%
>=65 years	16 66.7%
Sex: Female, Male (Count of Participants)
Female	15 62.5%
Male	9 37.5%
Region of Enrollment (participants) [Number]
United States	24 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility
Description	Feasibility assessed by number of participants with successful completion of biopsy (i.e. a biopsy was able to be obtained to collect a tissue sample)
Time Frame	Immediately following procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Assessing Peripheral Pulmonary Nodules
Arm/Group Description	To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
Measure Participants	24
Number [participants]	24 100%

2. Primary Outcome

Title	Incidence of Pneumothorax
Description	Presence of pneumothorax assessed in participants with successful completion of biopsy.
Time Frame	Immediately after procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Assessing Peripheral Pulmonary Nodules
Arm/Group Description	To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
Measure Participants	24
Number [participants]	5 20.8%

3. Secondary Outcome

Title	Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone
Description	Positive diagnostic yield of bronchoscopic biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) alone was defined by participants having benign or malignant pathology.
Time Frame	Approximately 1 week upon receipt of pathology report

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Assessing Peripheral Pulmonary Nodules
Arm/Group Description	To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
Measure Participants	24
Number [participants]	19 79.2%

4. Secondary Outcome

Title	Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB
Description	Positive diagnostic yield of bronchoscopic biopsy of ETTNA + EBUS + NB was defined by participants having benign or malignant pathology.
Time Frame	Approximately 1 week upon receipt of pathology report

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Assessing Peripheral Pulmonary Nodules
Arm/Group Description	To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
Measure Participants	24
Number [participants]	21 87.5%

Adverse Events

Arm/Group Title	Assessing Peripheral Pulmonary Nodules
Arm/Group Description	To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
All Cause Mortality
	Assessing Peripheral Pulmonary Nodules
	Affected / at Risk (%)	# Events
Total	0/24 (0%)
Serious Adverse Events
	Assessing Peripheral Pulmonary Nodules
	Affected / at Risk (%)	# Events
Total	0/24 (0%)
Other (Not Including Serious) Adverse Events
	Assessing Peripheral Pulmonary Nodules
	Affected / at Risk (%)	# Events
Total	0/24 (0%)
Respiratory, thoracic and mediastinal disorders
Hemoptysis	0/24 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.