Clinical trial NCT02978170: CBCT in Guiding Bronchoscopy in Patients With Lung Lesions
Official title: A New Guide for Our Guided-Bronchoscopy: The Use of Cone-Beam CT to Enhance Navigation and Diagnostic Yield of RP-EBUS and Hybrid Bronchoscope for Peripheral Lung Nodules Suspicious for Malignancy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Mass
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-11-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot clinical trial studies how well cone-beam computed tomography (CBCT) works in guiding bronchoscopy in patients with lung lesions. CBCT during bronchoscopy may help doctors to biopsy lung lesions that are harder to reach.

Detailed description: PRIMARY OBJECTIVES:

I. To describe the feasibility of using CBCT as an additional aid to guided-bronchoscopy with radial probe endobronchial ultrasound (RP-EBUS)/hybrid scope for the diagnosis of peripheral lung nodules.

SECONDARY OBJECTIVES:

I. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS (RP-EBUS-navigation yield) and confirmed with CBCT.

II. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS and samples are diagnostic (diagnostic yield-RP-EBUS).

III. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS, samples were non-diagnostic, and CBCT prompted further tool re-location (i.e. change of needle angle, change of tool) leading to diagnosis.

IV. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is not identified by RP-EBUS, and CBCT-aided navigation allowed the operator to reach the lesion (CBCT-added navigation yield).

V. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is not identified by RP-EBUS and CBCT-aided navigation allowed the operator to reach the lesion and obtain a diagnosis (CBCT-added diagnostic yield).

VI. Describe the relationship between RP-PROBE and target (contact/no contact; central/peripheral).

VII. Describe the relationship between needle tip and target (contact/no contact; central/peripheral).

VIII. Describe the influence of points 6 and 7 on diagnostic yield. IX. Describe fluoroscopy time. X. Describe estimated amount of radiation generated by CBCT use. XI. Describe bronchoscopy time (first scope in/last scope out). XII. Describe the proportion of patients in whom molecular analysis for lung cancer (i.e. EGFR, K-RAS, ALK) can be performed.

OUTLINE:

Patients undergo CBCT during standard of care bronchoscopy.

After completion of study, patients with lesions found not to be cancerous are followed up for 6 months to watch for changes (standard care).

Eligibility criteria: Inclusion Criteria:

* Patients undergoing guided-bronchoscopy for diagnosis of peripheral lung lesion/s \> 1 and \< 3 cm in diameter located in the outer 2/3 of the lung fields

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient with indications for mediastinal lymph node (LN) sampling per 13th American College of Clinical Pharmacy (ACCP) guidelines
* Patient with metastatic disease (from primaries other than lung) who have suspicious mediastinal or hilar LN that require sampling
* Patients with contraindication/s 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: Feasibility based on percentage of patients where researchers can locate target and bronchoscopic tools with cone-beam computed tomography
timeFrame: Up to 6 months
Secondary outcomes:
measure: Proportion of patients with peripheral nodules undergoing bronchoscopy in different subsample
timeFrame: Up to 6 months
measure: Localization of the tip with respect to targets
timeFrame: Up to 6 months
measure: Diagnostic yield
timeFrame: Up to 6 months
measure: Amount of radiation generated by cone-beam computed tomography use
timeFrame: Up to 6 months
measure: Fluoroscopy/bronchoscopy time
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 Casal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Casal RF, Sarkiss M, Jones AK, Stewart J, Tam A, Grosu HB, Ost DE, Jimenez CA, Eapen GA. Cone beam computed tomography-guided thin/ultrathin bronchoscopy for diagnosis of peripheral lung nodules: a prospective pilot study. J Thorac Dis. 2018 Dec;10(12):6950-6959. doi: 10.21037/jtd.2018.11.21.