CBCT in Guiding Bronchoscopy in Patients With Lung Lesions

A New Guide for Our Guided-Bronchoscopy: The Use of Cone-Beam CT to Enhance Navigation and Diagnostic Yield of RP-EBUS and Hybrid Bronchoscope for Peripheral Lung Nodules Suspicious for Malignancy: A Pilot Study

This pilot clinical trial studies how well cone-beam computed tomography (CBCT) works in guiding bronchoscopy in patients with lung lesions. CBCT during bronchoscopy may help doctors to biopsy lung lesions that are harder to reach.

Study Overview

• Status: Completed
• Conditions: Pulmonary Mass
• Intervention / Treatment: Procedure: Cone-Beam Computed Tomography

Detailed Description

PRIMARY OBJECTIVES:

I. To describe the feasibility of using CBCT as an additional aid to guided-bronchoscopy with radial probe endobronchial ultrasound (RP-EBUS)/hybrid scope for the diagnosis of peripheral lung nodules.

SECONDARY OBJECTIVES:

I. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS (RP-EBUS-navigation yield) and confirmed with CBCT.

II. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS and samples are diagnostic (diagnostic yield-RP-EBUS).

III. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS, samples were non-diagnostic, and CBCT prompted further tool re-location (i.e. change of needle angle, change of tool) leading to diagnosis.

IV. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is not identified by RP-EBUS, and CBCT-aided navigation allowed the operator to reach the lesion (CBCT-added navigation yield).

V. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is not identified by RP-EBUS and CBCT-aided navigation allowed the operator to reach the lesion and obtain a diagnosis (CBCT-added diagnostic yield).

VI. Describe the relationship between RP-PROBE and target (contact/no contact; central/peripheral).

VII. Describe the relationship between needle tip and target (contact/no contact; central/peripheral).

VIII. Describe the influence of points 6 and 7 on diagnostic yield. IX. Describe fluoroscopy time. X. Describe estimated amount of radiation generated by CBCT use. XI. Describe bronchoscopy time (first scope in/last scope out). XII. Describe the proportion of patients in whom molecular analysis for lung cancer (i.e. EGFR, K-RAS, ALK) can be performed.

OUTLINE:

Patients undergo CBCT during standard of care bronchoscopy.

After completion of study, patients with lesions found not to be cancerous are followed up for 6 months to watch for changes (standard care).

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing guided-bronchoscopy for diagnosis of peripheral lung lesion/s > 1 and < 3 cm in diameter located in the outer 2/3 of the lung fields

Exclusion Criteria:

• Pregnant or breastfeeding women
• Patient with indications for mediastinal lymph node (LN) sampling per 13th American College of Clinical Pharmacy (ACCP) guidelines
• Patient with metastatic disease (from primaries other than lung) who have suspicious mediastinal or hilar LN that require sampling
• Patients with contraindication/s for general anesthesia (e.g., severe and active coronary artery disease, chronic obstructive pulmonary disease [COPD] with forced expiratory volume in 1 second [FEV1] < 1 liter, uncontrolled hypertension, increased intracranial pressure, history of intolerance to general anesthesia)
• Dementia or other severe cognitive impairment causing inability to understand or consent to the procedure and study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Diagnostic (CBCT); Patients undergo CBCT during standard of care bronchoscopy.	Procedure: Cone-Beam Computed Tomography; Undergo CBCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility based on percentage of patients where researchers can locate target and bronchoscopic tools with cone-beam computed tomography	Will be considered feasible if researchers can locate target and bronchoscopic tools with cone-beam computed tomography in at least 80% of the patients (16 out of the 20 participants) that are enrolled.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with peripheral nodules undergoing bronchoscopy in different subsample	Will conduct extensive descriptive analyses of the data collected. Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.	Up to 6 months
Localization of the tip with respect to targets	Will assess the relationship between radial probe/needle tip and target. Will conduct extensive descriptive analyses of the data collected. Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.	Up to 6 months
Diagnostic yield	Will assess the influence of points 6 and 7 on diagnostic yield. Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.	Up to 6 months
Amount of radiation generated by cone-beam computed tomography use	Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.	Up to 6 months
Fluoroscopy/bronchoscopy time	Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.	Up to 6 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Casal RF, Sarkiss M, Jones AK, Stewart J, Tam A, Grosu HB, Ost DE, Jimenez CA, Eapen GA. Cone beam computed tomography-guided thin/ultrathin bronchoscopy for diagnosis of peripheral lung nodules: a prospective pilot study. J Thorac Dis. 2018 Dec;10(12):6950-6959. doi: 10.21037/jtd.2018.11.21.

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 28, 2016
• Primary Completion (ACTUAL): May 4, 2019
• Study Completion (ACTUAL): May 4, 2019

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (ESTIMATE): November 30, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2019
• Last Update Submitted That Met QC Criteria: May 31, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2016-0466 (M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); NCI-2017-00628 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No