CBCT-Guided Navigational Bronchoscopy For Lung Nodules

Lung; Node Clinical Trial

Official title:

Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules: A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758403
• Other study ID #: 20-580
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: August 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: Adnan Majid, MD
• Phone: (617) 632-8252
• Email: amajid[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cone Beam Computed Tomography
• Guided Navigation Bronchoscopy
• Lung; Node
• Multiple Pulmonary Nodules
• Peripheral Pulmonary Nodules

Intervention

Radiation:
• Navigation Bronchoscopy
Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.
• Cone beam computed tomography (CBCT)
Per Protocol

Locations

Country	Name	City	State
United States	Beth Israel Deaconness Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Dana-Farber Cancer Institute, Philips Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Diagnostic Yield	The overall diagnostic yield will be calculated by adding the number of true positives (TP) for both malignancy and benign disease in the numerator and dividing by the total number of procedures performed for each arm of the study.; Proportions will be compared with the Chi-Square Test as this test is equivalent to the z-test of two proportions (26). A p-value <0.05 will be considered as statistically significant.	6 months
Secondary	Overall incidence of procedure-related complications	To compare complications between navigational bronchoscopy alone and CBCT guided bronchoscopy.	6 months
Secondary	Additional diagnostic procedures in navigational bronchoscopy alone and CBCT guided bronchoscopy.	To compare the need of additional diagnostic procedures in navigational bronchoscopy alone and CBCT guided bronchoscopy.	6 Months
Secondary	Navigational time in bronchoscopy alone and CBCT guided bronchoscopy.	To compare the navigational time defined as the time between the start of catheter driving after registration until catheter is parked for biopsy.	6 Months