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



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:9/28/2018
Start Date:February 14, 2018
End Date:January 2020

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

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.

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.

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.
We found this trial at
9
sites
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Phone: 206-386-2450
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Phone: 404-616-7349
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Atlanta, GA
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Phone: 410-955-5288
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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Chapel Hill, North Carolina
Phone: 919-445-0367
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Chapel Hill, NC
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171 Ashley Avenue
Charleston, South Carolina 29425
Phone: 843-792-6696
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Charleston, SC
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Durham, North Carolina 27705
Phone: 919-668-3812
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Durham, NC
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Phoenix, Arizona 85006
Phone: 602-521-3189
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Phoenix, AZ
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Phone: 412-864-3368
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Saint Louis, Missouri 63110
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Saint Louis, MO
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