Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )

Completed · Not applicable

Conditions studied: Pulmonary Lesions, Pulmonary Nodules, Pulmonary Mass

In brief

The purpose of this study is to compare the yield of two methods for obtaining a lung tissue sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound (R-EBUS). These two procedures are similar in that they both: (1) enable your doctor to look inside your lungs with a device called a bronchoscope, and (2) Use fluoroscopy, which is a technique that uses X-rays to see your lungs. This will give the doctor an opportunity to use either of the bronchoscopy methods described above and compare the tests to see if R-EBUS provides better results than standard bronchoscopy.

Key facts

Study ID

NCT02146131

Run by

Medical University of South Carolina

People needed

339

Starts

2014-07-01

Expected to finish

2017-07-14

Last updated by the study team

2018-09-25

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a solid lung lesion 2-5cm identified on chest CT with the intention to undergo bronchoscopic evaluation. If the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up >75% of the lesion and measure at 2-5cm.The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient. This will include patients determined to have an intermediate risk of malignancy (5-65%) and those non-surgical candidate with higher risk lesions in need of diagnosis for alternative treatment. OR
• Patients with a solid lung lesion 2-5cm identified on chest CT that are surgical candidates with a high probability of cancer (>65%) will be referred for surgical evaluation. If the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up >75% of the lesion and measure at 2-5cm. If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study. All sites will use the same online calculator to document probability of malignancy.
• Are at least 22 years old,
• Lack Bleeding disorders, and
• Are able to provide informed consent

You may not qualify if…

• Patients with a pure ground-glass opacity identified on chest CT
• Patients with endobronchial involvement seen on chest CT.
• Patients who refuse to participate,
• Are less than 22 years of age,
• Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure, and
• Are unable to provide informed consent
• Pregnant

Where it is running

• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Washington University Saint Louis — St Louis, Missouri, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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