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

NCT04995172 | Completed

• 2 other identifiers: 2020-0760NCI-2021-01331
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Navigational yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules

  Up to 6 months

• Diagnostic yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules

  Up to 6 months

• Mobile-CT (M-CT) added navigational yield

  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

  Up to 6 months

• Anatomical and procedural characteristics that can influence navigational and diagnostic yield

  Up to 6 months

Study Arms (1)

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; Other: Electronic Health Record Review; Procedure: Endobronchial Ultrasound Bronchoscopy

Interventions

Computed Tomography PROCEDURE

Undergo mobile CT-assisted bronchoscopy

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Observational (CT-assisted bronchoscopy, chart review)

Electronic Health Record Review OTHER

Patients' medical records are reviewed

Observational (CT-assisted bronchoscopy, chart review)

Endobronchial Ultrasound Bronchoscopy PROCEDURE

Undergo radial probe EBUS

Also known as: EBUS, Endobronchial Ultrasound

Observational (CT-assisted bronchoscopy, chart review)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Roberto F Casal

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 6, 2021
• Study Start: April 19, 2021
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

US (1)