TBNA vs EBUS-TBNA Plus Transbronchial Mediastinal Cryobiopsy for Adequacy

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 ;

Study Design

Related Conditions & MeSH terms

Lung Cancer

Clinical Trial Details

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

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms