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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Device: Veran System

• Registration Number: NCT03338049
• Lead Sponsor: Veran Medical Technologies

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.

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-09
• Study Start: 2018-02-14
• Primary Completion: 2019-10-29
• Study Completion: 2019-12-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Veran System	Veran System	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

Primary Outcome Measures

Name	Time	Method
Diagnostic Yield	Up to one year post index procedure	Diagnostic yield associated with either EMN-bronchoscopy or EMN-TTNA

Secondary Outcome Measures

Name	Time	Method
Adverse Events	30 days post index procedure	Rate of all device and procedure related events
Serious Adverse Events	30 days post index procedure	All device and/or procedure related serious adverse 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

Trial Locations

Locations (9)

Banner University Medical Center - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

University of North Carolina Medical Center; 🇺🇸 Chapel Hill, North Carolina, United States

Washington University Medical Center; 🇺🇸 Saint Louis, Missouri, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Medical University of South Carolina Medical Center; 🇺🇸 Charleston, South Carolina, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States