Status:
TERMINATED
CBCT-Guided Navigational Bronchoscopy For Lung Nodules
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Philips Healthcare
Dana-Farber Cancer Institute
Conditions:
Peripheral Pulmonary Nodules
Lung; Node
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04758403
Start Date
March 5 2021
End Date
April 12 2023
Last Update
November 19 2024
Active Locations (1)
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1
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215