All in One Study: A Prospective Trial of Electromagnetic Navigation for Biopsy of Pulmonary Nodules

Study Overview
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Brief Summary
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This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting.

Detailed Description
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The objectives of this study are to evaluate diagnostic yield following biopsy of peripheral pulmonary nodules as identified on chest computed tomography (CT) utilizing (1) Electromagnetic navigation (EMN) bronchoscopy, and/or (2) EMN-transthoracic needle aspiration (TTNA). Overall diagnostic yield will be evaluated to assess the combination of these approaches.

Official Title
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Multicenter, Prospective Trial of ElectromagnetIc Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Veran System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is ≥21 years old, The patient has a lung nodule identified on chest CT and is a candidate for elective EMN bronchoscopic evaluation as determined by the treating pulmonologist, The size of the target nodule, as measured at its greatest diameter, is between 1-3cm, Staging at the time of enrollment indicates NO/N1 (does not involve lymph nodes or includes involvement in nodes within ipsilateral hilum), The patient has an intermediate risk of malignancy (5-65% per the Mayo Model) and is in need of diagnosis for alternative treatment, OR The patient has a high probability of cancer (>65%) and will be referred for surgical evaluation or stereotactic body radiation therapy (SBRT). Note: If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study, The patient has a lack of bleeding disorders, and The patient is willing and able to provide informed consent. Exclusion Criteria: The patient is pregnant as confirmed by urine or serum pregnancy testing, The patients has a body mass index (BMI) >40, There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients with a nodule within SPiNPerc range (i.e. The patient would not go on for a CT guided TTNA), OR There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients where the target nodule is within a region considered to be not accessible to a percutaneous approach as determined by the radiology core lab and thus would prevent a confirmatory tissue diagnosis before SBRT.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Veran System<br>Staged biopsy sampling methodology. If lymph node staging is negative, EMN-bronchoscopy will be performed. If EMN-bronchoscopy is negative, EMN-TTNA will be performed | Device: Veran System<br>* Electromagnetic navigation bronchoscopy and electromagnetic navigation transthoracic needle aspiration<br>* Other names: Veran SPiN Thoracic Navigation System SPiNPerc Kit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Yield | Diagnostic yield associated with either EMN-bronchoscopy or EMN-TTNA | Up to one year post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | All device and/or procedure related serious adverse events | 30 days post index procedure | 
| Adverse Events | Rate of all device and procedure related events | 30 days post index procedure | 
| Rate of procedure cancellation | Impact of same day CT scan on rate of procedure cancellations due decrease in nodule size | On procedure day | 
| Procedural Factors | Number of instrument passes, type of instrument, site of biopsy | Intra-procedure |