22-gauge ProCore Needle v. Standard 22-gauge (P00030500)

Study Overview
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Brief Summary
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The purpose of this study is to compare the usefulness of two needles (used for obtaining a lung tissue sample : (1) standard 22-gauge, and (2) ProCore 22-gauge) for endobronchial ultrasound

Detailed Description
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The purpose of this study is to compare the usefulness of two needles used for obtaining a lung tissue sample: (1) standard 22-gauge, and (2) ProCore 22-gauge. Both of these needles are used to get biopsies (samples) of lung tissue. The standard needle has one bevel (angled side of the needle formed when it is sharpened to make a point), while the ProCore needle has 2 bevels. The standard needle is more commonly used and we are doing this study to see if the ProCore needle would be more useful. The investigator in charge of this study is Dr. Nichole T. Tanner. This study is being done at four sites and will involve approximately 200 volunteers.

Official Title
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A Multi-center Study Comparing Standard 22-gauge and 22-gauge ProCore Needles for Endobronchial Ultrasound

Conditions
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Quantity of Tissue Obtained, Quality of Tissue Obtained, Ease of Use of 22-gauge ProCore EBUS Needles and the Standard 22-gauge Needles

Intervention / Treatment
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* Other: 22-gauge Standard Needle
* Other: 22-gauge ProCore Needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node >1 cm in short axis or a normal sized lymph node with uptake on FDG-PET scan that is higher than background PET activity. Participants must be at least 18 years old or older, lack bleeding disorders, and be able to provide informed consent. The latter two criteria will be assessed from the patient's history and the consenting interview. Exclusion Criteria: Subjects who refuse to participate, or demonstrate inability to give informed consent Subjects who are less than 18 years of age Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary) Subjects on anticoagulation (other than Aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 22-gauge Standard Needle<br>Participants will have each node sampled starting with the standard 22G needle on the first pass followed by the ProCore 22G needle on the second pass (for a total of 8 passes) | Other: 22-gauge Standard Needle<br>* Acquisition of lymph nodes samples using the 22-gauge Standard Needle, following subject-sedation and the introduction of an EBUS scope into the airway.<br>|
| Active Comparator: 22-gauge ProCore Needle<br>Participants will have each node sampled starting with the ProCore 22G on the first pass followed by the standard 22G needle on the second pass (for a total of 8 passes) | Other: 22-gauge ProCore Needle<br>* Acquisition of lymph nodes samples using the 22-gauge ProCore Needle, following subject-sedation and the introduction of an EBUS scope into the airway.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use of 22-gauge ProCore EBUS needles and the standard 22-gauge needles. |  | Within two weeks from the day of the procedure | 
| Quality of tumor obtained (measured by cell block and ability to perform mutational analysis) |  | Within two weeks from the day of the procedure | 
| Quantity of tissue obtained (measured by number of unstructured fragments) |  | Within two weeks from the day of the procedure |