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Completed

NCT Number: NCT04159025

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoreDx Pulmonary Mini-Forceps

Device

Manufactured by Boston Scientific

Other names: Endobronchial ultrasound guided mini-forceps

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. Rate of Adverse Events

    Time frame: Through 24 hours after biopsy procedure

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

EBUS-Miniforceps Biopsy Specimen Acquisition for PD-L1 Testing in Nonsmall Cell Lung Cancer: A Feasibility Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 12, 2019
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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