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

Study 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.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedEndobronchial ultrasound with transbronchial needle aspiration and Bronchoscopy

Plus 1 other study approaches.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 2, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 4

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Vanderbilt-Ingram Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Diagnostic
Study type: Interventional
Phase: Phase 4
Sponsor: Vanderbilt-Ingram Cancer Center
Interventions being studied: Procedure: Endobronchial ultrasound with transbronchial needle aspiration; Procedure: Bronchoscopy; Procedure: Cryobiopsy

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Lesions on PET or CT concerning for primary or metastatic malignancy that are amenable to biopsy by linear EBUS
Malignant cells present on rapid on-site cytological evaluation (ROSE)

Reasons someone may not be able to joinExclusion criteria

Patient is known to be less than 18 years old
Patient is known to be pregnant
Patient is known to be a prisoner
Operator deems lesion is not safe to biopsy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Vanderbilt University/Ingram Cancer CenterNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 2, 2026. Always confirm current availability with the study team.

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