Feasibility of Mobile-CT-Assisted Bronchoscopy for the Diagnosis of Lung Lesion
NCT ID: NCT04995172
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
72 participants
OBSERVATIONAL
2021-04-19
2024-11-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Computed Tomography
Undergo mobile CT-assisted bronchoscopy
Electronic Health Record Review
Patients' medical records are reviewed
Endobronchial Ultrasound Bronchoscopy
Undergo radial probe EBUS
Interventions
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Computed Tomography
Undergo mobile CT-assisted bronchoscopy
Electronic Health Record Review
Patients' medical records are reviewed
Endobronchial Ultrasound Bronchoscopy
Undergo radial probe EBUS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Roberto F Casal
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2021-01331
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0760
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0760
Identifier Type: -
Identifier Source: org_study_id