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

Lung Cancer Clinical Trial

— AIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338049
• Other study ID #: VMT AIO 2017
• Status: Completed
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: May 2020
• Source: Veran Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 1, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules

Intervention

Device:
• Veran System
Electromagnetic navigation bronchoscopy and electromagnetic navigation transthoracic needle aspiration

Locations

Country	Name	City	State
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	Medical University of South Carolina Medical Center	Charleston	South Carolina
United States	Duke University Hospital	Durham	North Carolina
United States	Banner University Medical Center - Phoenix	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Washington University Medical Center	Saint Louis	Missouri
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Veran Medical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Yield	Diagnostic yield associated with either EMN-bronchoscopy or EMN-TTNA	Up to one year post index procedure
Secondary	Serious Adverse Events	All device and/or procedure related serious adverse events	30 days post index procedure
Secondary	Adverse Events	Rate of all device and procedure related events	30 days post index procedure
Secondary	Rate of procedure cancellation	Impact of same day CT scan on rate of procedure cancellations due decrease in nodule size	On procedure day
Secondary	Procedural Factors	Number of instrument passes, type of instrument, site of biopsy	Intra-procedure