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

This is an interventional diagnostic trial for Lung Cancer Read More

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.