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

NCT ID: NCT04159025

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-08
• Study Completion Date: 2022-02-25

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.

Conditions

Non Small Cell Lung Cancer; NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Endobronchial ultrasound guided miniforceps biopsy

• Standard of care convex-probe endobronchial ultrasound and transbronchial needle aspiration followed by rapid on-site evaluation. If evaluation yields a diagnosis of nonsmall cell lung cancer then EBUS-MFB will be performed.
• With the EBUS bronchoscope, 6 needle punctures will be made into the targeted lymph node with the 22 gauge aspiration needle. The needle will be removed and the 1mm miniforceps will be passed through the working channel of the EBUS-bronchoscope into the targeted lymph node through the puncture site made using the 22 gauge needle using continuous endobronchial ultrasound guidance. The miniforceps will be used to obtain a core biopsy of the targeted lymph node - 8 core biopsies will be obtained from each targeted lymph node using this technique

Group Type: EXPERIMENTAL

CoreDx Pulmonary Mini-Forceps

Intervention Type: DEVICE

Manufactured by Boston Scientific

Interventions

CoreDx Pulmonary Mini-Forceps

Manufactured by Boston Scientific

Intervention Type: DEVICE

Other Intervention Names

Endobronchial ultrasound guided mini-forceps

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

201910132

Identifier Type: -

Identifier Source: org_study_id