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

Lung Neoplasm Clinical Trial

Official title:

Mobile-CT-Assisted Bronchoscopy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04995172
• Other study ID #: 2020-0760
• Secondary ID: NCI-2021-0133120
• Status: Active, not recruiting
• Start date: April 19, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms

Intervention

Procedure:
• Computed Tomography
Undergo mobile CT-assisted bronchoscopy

Other:
• Electronic Health Record Review
Patients' medical records are reviewed

Procedure:
• Endobronchial Ultrasound Bronchoscopy
Undergo radial probe EBUS

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Procedure duration	Will be summarized by mean (standard deviation [SD]) or median (interquartile range [IQR]).	Up to 6 months
Secondary	Time required to obtain mobile CT scans	Will be summarized by mean (SD) or median (IQR).	Up to 6 months
Secondary	Fluoroscopy time	Will be summarized by mean (SD) or median (IQR).	Up to 6 months
Secondary	Radiation dose to the patient	Will be summarized by mean (SD) or median (IQR).	Up to 6 months
Secondary	Procedural complications	Complications will be tabulated.	Up to 6 months

External Links

•   MD Anderson Cancer Center Website