Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy

Peripheral Pulmonary Nodules Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109458
• Other study ID #: NA_00086035
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: February 4, 2016
• Start date: September 2013
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Peripheral Pulmonary Nodules

Intervention

Device:
• Navigation guided bronchoscopy

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Veran Medical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the diagnostic yield of using navigation guided transthoracic needle aspiration (N-TTNA) and navigation guided bronchoscopy (NB) in the evaluation of PPN.	Primary outcome of diagnostic yield will be determined from the results of the bronchoscopy. A biopsy that results in a specific diagnosis, either malignant or benign, will be assumed to be a true positive. Plan for further diagnostic management for patients who have a non-diagnostic biopsy will be determined by the attending physician. Those patients will be followed for up to 6 months until a definitive diagnosis has been made (such as from surgical pathology), or the lesion has decreased on repeat CT imaging.	Patients will be followed for up to 6 months or until a definitive diagnosis has been made	No
Secondary	Adverse event rates of hemoptysis and pneumothorax	Monitor the safety of the navigational bronchoscopy combined with the navigation transthoracic needle aspiration	Patients will be followed for up to six months or until a definitive diagnosis is made	Yes