RecruitingPhase 4NCT06105801

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

Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

250 participants

Start Date

Sep 13, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods of collecting tissue samples from lymph nodes and tumors in the chest (mediastinum) to see which produces better-quality tissue for advanced genetic testing (next-generation sequencing). The two methods are: a standard needle biopsy (EBUS-TBNA) and a newer freezing biopsy technique (transbronchial cryobiopsy). **You may be eligible if...** - You have an abnormal lymph node or chest mass on PET or CT scan that is being evaluated for possible cancer - The mass is reachable by a bronchoscopy-guided needle biopsy (EBUS) - Cancer cells were seen on a rapid on-site examination of the initial sample **You may NOT be eligible if...** - You are under 18 years old - You are pregnant - You are incarcerated - The doctor determines the biopsy site is not safe to sample Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.