Clinical trial NCT04159025: EBUS-Miniforceps Biopsy Specimen Acquisition for PD-L1 Testing in Nonsmall Cell Lung Cancer
Official title: EBUS-Miniforceps Biopsy Specimen Acquisition for PD-L1 Testing in Nonsmall Cell Lung Cancer: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
NSCLC
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2019-11-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: 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
timeFrame: Completion of biopsy (day 1)
Secondary outcomes:
measure: Rate of Adverse Events
timeFrame: Through 24 hours after biopsy procedure
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Alexander Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: