Pulmonary Mass Clinical Trial
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
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.
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).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02146131 -
Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )
|
N/A | |
| Completed |
NCT00917137 -
Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy
|
N/A |