All in One Study: A Prospective Trial of Electromagnetic Navigation for Biopsy of Pulmonary Nodules (NCT03338049) | Clinical Trial Compass
CompletedNot Applicable
All in One Study: A Prospective Trial of Electromagnetic Navigation for Biopsy of Pulmonary Nodules
United States150 participantsStarted 2018-02-14
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 n…