TBNA vs EBUS-TBNA Plus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing — META-Gen  

Lung Cancer Clinical Trial

Official title: A Multicenter Randomized Trial of EBUS-TBNA Versus EBUS-TBNA Plus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing the META-Gen Study

Status Not yet recruiting

Clinical Trial Summary

This is a multi-center, clinical trial evaluating the effect of adding transbronchial mediastinal cryobiopsy to EBUSTBNA 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 acquisition of tissue for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE of a mediastinal 8 lymph node or mass suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a transbronchial mediastinal cryobiopsy.

Clinical Trial Description

Primary Objective:

• To evaluate the utility of adding transbronchial mediastinal cryobiopsy to endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) 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:

• 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 ;

Related Conditions & MeSH terms

• Lung Cancer

• NCT number: NCT06105801
• Study type: Interventional
• Source: Vanderbilt-Ingram Cancer Center
• Contact: Vanderbilt-Ingram Services for Timely Access
• Phone: 800-811-8480
• Email: cip@vumc.org
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 31, 2024
• Completion date: October 31, 2028