Status:
COMPLETED
All in One Study: A Prospective Trial of Electromagnetic Navigation for Biopsy of Pulmonary Nodules
Lead Sponsor:
Veran Medical Technologies
Conditions:
Lung Cancer
Eligibility:
All Genders
21+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03338049
Start Date
February 14 2018
End Date
December 1 2019
Last Update
May 19 2020
Active Locations (9)
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1
Banner University Medical Center - Phoenix
Phoenix, Arizona, United States, 85006
2
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
3
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
4
Washington University Medical Center
St Louis, Missouri, United States, 63110