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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159025
• Other study ID #: 201910132
• Status: Completed
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: February 25, 2022

Study information

• Verified date: February 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 25, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer
• NSCLC

Intervention

Device:
• CoreDx Pulmonary Mini-Forceps
Manufactured by Boston Scientific

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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	Completion of biopsy (day 1)
Secondary	Rate of Adverse Events		Through 24 hours after biopsy procedure

External Links

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