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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

Who can join

Ages 18 and older · All sexes

Inclusion 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)

Exclusion 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

About the study

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.

What is being tested

• Endobronchial ultrasound with transbronchial needle aspiration (procedure)
• Bronchoscopy (procedure)
• Cryobiopsy (procedure)

Sponsor: Vanderbilt-Ingram Cancer Center · Participants: 250 · Started: Sep 13, 2024

Contact the study team

• Vanderbilt-Ingram Services for Timely Access · Phone: 800-811-8480

Official record on ClinicalTrials.gov — NCT06105801

Locations in the U.S.

Conditions

• Lung Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.