Peripheral Pulmonary Nodules
Conditions
Keywords
Lung nodule biopsy
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.
Interventions
DEVICENavigation guided bronchoscopy
Navigation guided transthoracic needle aspiration (N-TTNA) and navigation guided bronchoscopy (NB); guidance system is by Veran Medical Technologies, Inc.
Sponsors
Veran Medical Technologies
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Incidence of Pneumothorax | Immediately after procedure | Presence of pneumothorax assessed in participants with successful completion of biopsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Assessing Peripheral Pulmonary Nodules 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 | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Assessing Peripheral Pulmonary Nodules |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Feasibility
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Assessing Peripheral Pulmonary Nodules | Feasibility | 24 participants |
Primary
Incidence of Pneumothorax
Presence of pneumothorax assessed in participants with successful completion of biopsy.
Time frame: Immediately after procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Assessing Peripheral Pulmonary Nodules | Incidence of Pneumothorax | 5 participants |
Secondary
Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Assessing Peripheral Pulmonary Nodules | Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone | 19 participants |
Secondary
Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Assessing Peripheral Pulmonary Nodules | Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB | 21 participants |