CompletedNot applicableNCT04159025
Official study title

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

Study 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.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedCoreDx Pulmonary Mini-Forceps

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Washington University School of Medicine

Study sponsor

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

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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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