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N/A N=20 Diagnostic

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

Non Small Cell Lung Cancer · NSCLC

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: 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 — 13 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
CoreDx Pulmonary Mini-Forceps (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Washington University School of Medicine
Primary completion
Feb 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
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
13
SECONDARY
Rate of Adverse Events

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04159025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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