CompletedNot applicableNCT04159025

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

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.

Checked against the public recordLast updated Mar 1, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations1
SponsorWashington University School of Medicine
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Not applicable
Sponsor
Washington University School of Medicine
Interventions being studied
Device: CoreDx Pulmonary Mini-Forceps
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
Treatment approach
03
Public criteria

Who may be able to participate

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 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Washington University School of MedicineSt Louis, Missouri

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 1, 2023. Always confirm current availability with the study team.

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