Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06105801

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

Led by Vanderbilt-Ingram Cancer Center · Updated on 2026-02-02

250

Participants Needed

1

Research Sites

215 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt-Ingram Cancer Center

Lead Sponsor

N

Northwestern Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

V

Vanderbilt-Ingram Services for Timely Access

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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