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

Completed · Not applicable

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT03338049

Run by

Veran Medical Technologies

People needed

150

Starts

2018-02-14

Expected to finish

2019-12-01

Last updated by the study team

2020-05-19

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Banner University Medical Center - Phoenix — Phoenix, Arizona, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Washington University Medical Center — St Louis, Missouri, United States
• University of North Carolina Medical Center — Chapel Hill, North Carolina, United States
• Duke University Hospital — Durham, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina Medical Center — Charleston, South Carolina, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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