Clinical trial NCT04995172: Feasibility of Mobile-CT-Assisted Bronchoscopy for the Diagnosis of Lung Lesion
Official title: Mobile-CT-Assisted Bronchoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with a peripheral lung lesion who are scheduled to undergo a bronchoscopy

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The added value of mobile-computed tomography (CT)-assisted bronchoscopy (M-CAB)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Navigational yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules
timeFrame: Up to 6 months
measure: Diagnostic yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules
timeFrame: Up to 6 months
measure: Mobile-CT (M-CT) added navigational yield
timeFrame: Up to 6 months
measure: Sensitivity for malignancy of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy and its increase (if any) provided by mobile-CT assistance
timeFrame: Up to 6 months
measure: Anatomical and procedural characteristics that can influence navigational and diagnostic yield
timeFrame: Up to 6 months
measure: Procedure duration
timeFrame: Up to 6 months
measure: Time required to obtain mobile CT scans
timeFrame: Up to 6 months
measure: Fluoroscopy time
timeFrame: Up to 6 months
measure: Radiation dose to the patient
timeFrame: Up to 6 months
measure: Procedural complications
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Roberto F Casal
role: PRINCIPAL_INVESTIGATOR
References: