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CBCT-Guided Navigational Bronchoscopy For Lung Nodules

Primary Purpose

Peripheral Pulmonary Nodules, Lung; Node, Cone Beam Computed Tomography

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Navigation Bronchoscopy

Cone beam computed tomography (CBCT)

About this trial

This is an interventional diagnostic trial for Peripheral Pulmonary Nodules focused on measuring Peripheral Pulmonary Nodules, Lung; Node, Cone Beam Computed Tomography, Guided Navigation Bronchoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Beth Israel Deaconness Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Navigation Bronchoscopy ALONE

CBCT-GUIDED Navigation Bronchoscopy

Arm Description

This research study involves a screening period, a procedure and follow up visits Procedure Visit Navigation Bronchoscopy Alone Follow-Up Visits at Week 1, 4 and 12

This research study involves a screening period, a procedure and follow up visits Procedure Visit- Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules -Follow-Up Visits at Week 1, 4 and 12

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall incidence of procedure-related complications

To compare complications between navigational bronchoscopy alone and CBCT guided bronchoscopy.

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.

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.

Full Information

NCT ID

NCT04758403

First Posted

February 14, 2021

Last Updated

August 31, 2023

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Philips Healthcare, Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT04758403

Brief Title

CBCT-Guided Navigational Bronchoscopy For Lung Nodules

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 5, 2021 (Actual)

Primary Completion Date

July 31, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Philips Healthcare, Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Navigation Bronchoscopy ALONE

Arm Type

Experimental

Arm Description

This research study involves a screening period, a procedure and follow up visits Procedure Visit Navigation Bronchoscopy Alone Follow-Up Visits at Week 1, 4 and 12

Arm Title

CBCT-GUIDED Navigation Bronchoscopy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Navigation Bronchoscopy

Other Intervention Name(s)

Intervention Description

Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.

Intervention Type

Radiation

Intervention Name(s)

Cone beam computed tomography (CBCT)

Intervention Description

Per Protocol

Primary Outcome Measure Information:

Title

Overall Diagnostic Yield

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Overall incidence of procedure-related complications

Description

To compare complications between navigational bronchoscopy alone and CBCT guided bronchoscopy.

Time Frame

6 months

Title

Additional diagnostic procedures in navigational bronchoscopy alone and CBCT guided bronchoscopy.

Description

To compare the need of additional diagnostic procedures in navigational bronchoscopy alone and CBCT guided bronchoscopy.

Time Frame

6 Months

Title

Navigational time in bronchoscopy alone and CBCT guided bronchoscopy.

Description

To compare the navigational time defined as the time between the start of catheter driving after registration until catheter is parked for biopsy.

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Adnan Majid, MD

Phone

(617) 632-8252

amajid@bidmc.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adnan Majid, MD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deaconness Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adnan Majid, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

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CBCT-Guided Navigational Bronchoscopy For Lung Nodules

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