Lung Cancer
Conditions
Brief summary
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
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.
Interventions
DEVICEVeran System
Electromagnetic navigation bronchoscopy and electromagnetic navigation transthoracic needle aspiration
Sponsors
Veran Medical Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield | Up to one year post index procedure | Diagnostic yield associated with either EMN-bronchoscopy or EMN-TTNA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | 30 days post index procedure | All device and/or procedure related serious adverse events |
| Adverse Events | 30 days post index procedure | Rate of all device and procedure related events |
| Rate of procedure cancellation | On procedure day | Impact of same day CT scan on rate of procedure cancellations due decrease in nodule size |
| Procedural Factors | Intra-procedure | Number of instrument passes, type of instrument, site of biopsy |
Countries
United States
Outcome results
None listed