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

Veran Medical Technologies

Status: Completed

Conditions: Lung Cancer

Treatments: Device: Veran System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03338049

VMT AIO 2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Veran System

Other group

Description:

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

Treatment:

Device: Veran System