Feasibility of Mobile-CT-Assisted Bronchoscopy for the Diagnosis of Lung Lesion

Mobile-CT-Assisted Bronchoscopy

This study investigates whether using a mobile-CT-assisted bronchoscopy (M-CAB) during a bronchoscopy procedure will better enable the study staff to reach the lung tumor, perform a biopsy, and obtain a diagnosis. One method that doctors use for diagnosing lung tumors is bronchoscopy guided by an X-ray machine (called fluoroscope). Though much better guidance could be provided with a CT scanner when compared to the fluoroscope, the standard CT equipment is very large, fixed in a radiology room, and difficult to use with bronchoscopy. Mobile CT imaging systems may more easily and effectively perform the same tasks of the standard CT imaging in the bronchoscopy room, offering better guidance than the standard fluoroscope.

Study Overview

• Status: Recruiting
• Conditions: Lung Neoplasm
• Intervention / Treatment: Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Endobronchial Ultrasound Bronchoscopy

Detailed Description

PRIMARY OBJECTIVE

I. To determine the added value of mobile-CT)-assisted bronchoscopy (M-CAB) for the diagnosis of peripheral lung nodules defined as the proportion of patients in whom bronchoscopy with radial-probe endobronchial ultrasound (RP-EBUS) and 2-D Fluoroscopy is non-diagnostic (lesion is not reached or rapid-onsite cytology is non-diagnostic) and diagnosis is obtained after utilizing mobile-CT assistance.

SECONDARY OBJECTIVES:

I. Describe the navigational yield of bronchoscopy with RP-EBUS/2-dimensional (2-D) fluoroscopy for peripheral nodules.

II. Describe the diagnostic yield of bronchoscopy with RP-EBUS/2-D fluoroscopy for peripheral nodules.

III. Describe the mobile-CT (M-CT) added navigational yield. IV. Describe the sensitivity for malignancy of bronchoscopy with RP-EBUS/2-D fluoroscopy and its increase (if any) provided by mobile-CT assistance.

V. Describe anatomical and procedural characteristics that can influence navigational and diagnostic yield (tumor location, tumor characteristics -solid, semisolid-, air-bronchus sign, biopsy tool, relationship between biopsy tool/tumor).

VI. Describe procedure duration. VII. Describe time required to obtain mobile CT scans VIII. Describe fluoroscopy time and estimate radiation dose to the patient. IX. Describe procedural complications.

OUTLINE:

Patients undergo RP-EBUS bronchoscopy per standard of care. If the study staff cannot reach the target lesion or is unable to determine a diagnosis, patients undergo bronchoscopy using mobile CT imaging. Patients' medical records are also reviewed for up to 6 months.

• Study Type: Observational
• Enrollment (Anticipated): 67

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Roberto F. Casal; Phone Number: 713-792-6238; Email: RFCasal@mdanderson.org
      • Principal Investigator: Roberto F. Casal

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with a peripheral lung lesion who are scheduled to undergo a bronchoscopy

Description

Inclusion Criteria:

• Patients of 18 years of age or older undergoing bronchoscopy for diagnosis of a peripheral lung lesion from 1 to 3.5 cm in diameter located in the outer 2/3 of the lung fields

Exclusion Criteria:

• Pregnant or breastfeeding women
• Patients who cannot tolerate raising both arms above their head (position for obtaining mobile-CT images)
• Patients with any contraindication 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

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (CT-assisted bronchoscopy, chart review); Patients undergo RP-EBUS bronchoscopy per standard of care. If the study staff cannot reach the target lesion or is unable to determine a diagnosis, patients undergo bronchoscopy using mobile CT imaging. Patients' medical records are also reviewed for up to 6 months.	Procedure: Computed Tomography; Undergo mobile CT-assisted bronchoscopy; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Other: Electronic Health Record Review; Patients' medical records are reviewed; Procedure: Endobronchial Ultrasound Bronchoscopy; Undergo radial probe EBUS; Other Names: EBUS; Endobronchial Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The added value of mobile-computed tomography (CT)-assisted bronchoscopy (M-CAB)	Defined as the proportion of patients in whom bronchoscopy with thin or ultrathin scope, radial-probe endobronchial ultrasound (RP-EBUS) and 2-dimensional (2-D) fluoroscopy is non-diagnostic (lesion is not reached or rapid-onsite cytology is non-diagnostic) and diagnosis is obtained after utilizing mobile-CT assistance. Descriptive statistics (mean standard deviation [SD] or median interquartile range [IQR], frequency [%]) will be used to summarize patient characteristics.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Navigational yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules	Navigational yield for standard of care (SOC) will be estimated along with 95% confidence intervals (CIs).	Up to 6 months
Diagnostic yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules	Diagnostic yield of SOC and diagnostic yield of SOC + M-CT along with their 95% CIs will be estimated.	Up to 6 months
Mobile-CT (M-CT) added navigational yield	M-CT added diagnostic yield in a subgroup with non-diagnostic subjects by SOC will be estimated along with its 95% CI. M-CT added diagnostic yield in a subgroup with non-diagnostic subjects by SOC will be estimated along with its 95% CI. Two-sided exact binomial test will be used to test if diagnostic yield of SOC + M-CT is significantly different from 0.2 in the subgroup.	Up to 6 months
Sensitivity for malignancy of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy and its increase (if any) provided by mobile-CT assistance	Sensitivity for malignancy of SOC and sensitivity for malignancy of SOC + M-CT will be estimated, considering final pathology as the gold standard test.	Up to 6 months
Anatomical and procedural characteristics that can influence navigational and diagnostic yield	Anatomic and procedural characteristics that are associated with navigational and diagnostic yield will be evaluated by multivariate logistic regression models. A p-value of less than 0.05 will indicate a statistical significance.	Up to 6 months
Procedure duration	Will be summarized by mean (standard deviation [SD]) or median (interquartile range [IQR]).	Up to 6 months
Time required to obtain mobile CT scans	Will be summarized by mean (SD) or median (IQR).	Up to 6 months
Fluoroscopy time	Will be summarized by mean (SD) or median (IQR).	Up to 6 months
Radiation dose to the patient	Will be summarized by mean (SD) or median (IQR).	Up to 6 months
Procedural complications	Complications will be tabulated.	Up to 6 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2020-0760 (Other Identifier: M D Anderson Cancer Center); NCI-2021-01331 (Registry Identifier: 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