EBUS-Miniforceps Biopsy Specimen Acquisition for PD-L1 Testing in Nonsmall Cell Lung Cancer

Not Applicable

Completed

• Conditions: NSCLC; Non Small Cell Lung Cancer
• Interventions: Device: CoreDx Pulmonary Mini-Forceps

• Registration Number: NCT04159025
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The incorporation of PD-L1 testing into clinical practice has progressed at a rapid pace, and now offers an additional line of therapy for eligible patients with nonsmall cell lung cancer. The assay used to detect circulating levels of PD-L1 currently requires core biopsies, and is not approved to be used for specimens collected through a needle based cytological technique. Though endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) has markedly improved the manner in which patients are diagnosed and staged for lung cancer, alternative means of tissue collection may be mandatory to offer patients access to newer lines of therapy such as PD-L1 inhibition. EBUS-miniforceps biopsy may allow bronchoscopists to obtain core biopsy specimens through the technique of endobronchial ultrasound, so that more invasive approaches such as surgery may be avoided. Feasibility using this approach would indicate that all patients being staged with endobronchial ultrasound procedures would be candidates for PD-L1 testing and potential therapy.

This study is proposed to evaluate the feasibility of using endobronchial ultrasound guided miniforceps biopsy (EBUS-MFB) to acquire tissue that is adequate for PD-L1 testing. Feasibility in this study is defined as the ability to obtain adequate material during EBUS procedures to perform PD-L1 testing.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-12
• Study Start: 2020-01-08
• Primary Completion: 2022-02-24
• Study Completion: 2022-02-25
• Results First Submitted: 2023-01-27
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-27
• Last Update Submitted: 2023-02-27
• Results First Posted: 2023-03-01
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with central lung lesion 1cm in size or larger identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
• Are at least 18 years old
• Are able to provide informed consent
• Are not pregnant as confirmed by bHCG testing prior to procedure

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Exclusion Criteria

• Patients who refuse to participate
• Are less than 18 years of age
• Are pregnant
• Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
• Are unable to provide informed consent
• Are on anticoagulant medications and who cannot safely discontinue their medication prior to their procedure at the recommendation of their treating physician

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endobronchial ultrasound guided miniforceps biopsy	CoreDx Pulmonary Mini-Forceps	* Standard of care convex-probe endobronchial ultrasound and transbronchial needle aspiration followed by rapid on-site evaluation. If evaluation yields a diagnosis of nonsmall cell lung cancer then EBUS-MFB will be performed. * With the EBUS bronchoscope, 6 needle punctures will be made into the targeted lymph node with the 22 gauge aspiration needle. The needle will be removed and the 1mm miniforceps will be passed through the working channel of the EBUS-bronchoscope into the targeted lymph node through the puncture site made using the 22 gauge needle using continuous endobronchial ultrasound guidance. The miniforceps will be used to obtain a core biopsy of the targeted lymph node - 8 core biopsies will be obtained from each targeted lymph node using this technique

Primary Outcome Measures

Name	Time	Method
Feasibility of Utilizing Endobronchial Ultrasound Guided Miniforceps as Assessed by the Number of Participants From Whom Adequate Amounts of Tissue to Perform PD-L1 Testing Was Acquired	Completion of biopsy (day 1)	* Adequacy will be defined as sufficient core biopsy material to perform the PD-L1 assay specific for nivolumab; * Any specimen in which the requested assay returns as "insufficient material to perform testing" will be deemed an "inadequate" specimen.; * Feasibility cannot be determined until the completion of biopsy for all patients enrolled

Secondary Outcome Measures

Name	Time	Method
Rate of Adverse Events	Through 24 hours after biopsy procedure

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States