NCT06105801

EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing

A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center clinical trial evaluating the effect of transbronchial mediastinal cryobiopsy for its ability to improve the likelihood of obtaining tissue sufficient for molecular analysis. Patients in outpatient clinics or pre-operative holding areas planning to undergo a bronchoscopic biopsy of a suspected malignant lesion (peripheral or mediastinal) for initial diagnosis, staging, or tissue acquisition for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a sampling.

Detailed description

Primary Objective: \- To evaluate the utility of transbronchial mediastinal cryobiopsy on its ability to improve the likelihood of acquiring tissue sufficient for next-generation sequencing (NGS). Safety Endpoints: * Pneumothorax within 7 days of procedure * Moderate bleeding defined as controlled with bronchoscope, saline, or epinephrine * Serious bleeding is defined as uncontrolled, leading to respiratory failure, need for transfusion, or cardiovascular instability * Respiratory failure is defined as a new oxygen requirement or escalation in oxygen delivery within 7 days of procedure * Unplanned hospitalization related to the procedure within 7 days of procedure * Death Exploratory Endpoints: * The proportion of samples adequate for NGS testing * The proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining * Proportion of samples that are adequate for complete NGS library sequencing * Estimated total number of tumor cells per H\&E-stained slide * Histological disease subtyping

Conditions

• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Endobronchial ultrasound with transbronchial needle aspiration	Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration
PROCEDURE	Bronchoscopy	Participants will undergo Bronchoscopy
PROCEDURE	Cryobiopsy	Participants will undergo Cryobiopsy

Timeline

• Start date: 2024-09-13
• Primary completion: 2027-10-31
• Completion: 2028-10-31
• First posted: 2023-10-30
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States