Boston, Massachusetts 02215

  • Guided Navigation Bronchoscopy

Purpose:

The purpose of this study is to determine if the cone beam computed tomography (CBCT)-guided navigation bronchoscopy is better in diagnosing lung nodules compared to navigation bronchoscopy alone.


Study summary:

This clinical trial examines the effectiveness of a treatment comparing it to another known treatment. The U.S. Food and Drug Administration (FDA) has approved the navigation bronchoscopy as a treatment option for this disease. The U.S. Food and Drug Administration (FDA) has approved the Cone-Beam CT scan as a treatment option for this disease. This research study involves a screening period, a procedure and follow up visits. The names of the study interventions involved in this study are: - Computed tomography (CBCT)-guided navigation bronchoscopy (CBCT-guided NB) - Navigation bronchoscopy alone Participants will receive the study procedure and will be followed for up to 6 months. It is expected that about 136 people will take part in this research study.


Criteria:

Inclusion Criteria: - Participants ≥18 years old. - Participants with lesions having an intermediate pre-test probability of malignancy (pCA, 0.05 to 0.65) as determined by Swensen-Mayo nodule risk calculator and in whom bronchoscopic biopsy was determined to be the next best treatment step by the treating pulmonologist. - Participants with higher risk lesions (pCA > 0.65) in need of a diagnosis for nonsurgical treatment or prior to surgery. - Participants are willing and able to provide informed consent. Exclusion Criteria: - The participant is pregnant as confirmed by urine or serum pregnancy testing. - There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in participant's with a nodule in the outer 1/3 lung zone (i.e. The participant would not go on for a CT guided TTNA). - Lacked fitness according to physician judgement to undergo bronchoscopy. - Contraindication for temporary interruption of the use of anticoagulant therapy. - Uncontrolled or irreversible coagulopathy. - Known allergy for lidocaine. - Uncontrolled pulmonary hypertension. - Recent (< 4 weeks) and/or uncontrolled cardiac disease. - Compromised upper airway (eg concomitant head and neck cancer or central airway stenosis such that endobronchial access is considered unsafe). - ASA classification ≥ 4. - COVID-19 positive participant at the time of procedure.


NCT ID:

NCT04758403


Primary Contact:

Principal Investigator
Fayez Kheir, MD
Beth Israel Deaconess Medical Center

Fayez Kheir, MD
Phone: (857) 207-4022
Email: fkheir@bidmc.harvard.edu


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 22, 2021

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