CBCT in Guiding Bronchoscopy in Patients With Lung Lesions
- Conditions
- Pulmonary Mass
- Interventions
- Procedure: Cone-Beam Computed Tomography
- Registration Number
- NCT02978170
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic (CBCT) Cone-Beam Computed Tomography Patients undergo CBCT during standard of care bronchoscopy.
- Primary Outcome Measures
Name Time Method Feasibility based on percentage of patients where researchers can locate target and bronchoscopic tools with cone-beam computed tomography Up to 6 months 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.
- Secondary Outcome Measures
Name Time Method Proportion of patients with peripheral nodules undergoing bronchoscopy in different subsample Up to 6 months 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.
Localization of the tip with respect to targets Up to 6 months 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.
Diagnostic yield Up to 6 months 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.
Amount of radiation generated by cone-beam computed tomography use Up to 6 months 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.
Fluoroscopy/bronchoscopy time Up to 6 months 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.
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States