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

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

Inclusion Criteria2

  • 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 Criteria4

  • 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

Interventions

PROCEDUREEndobronchial ultrasound with transbronchial needle aspiration

Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration

PROCEDUREBronchoscopy

Participants will undergo Bronchoscopy

PROCEDURECryobiopsy

Participants will undergo Cryobiopsy


Locations(1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

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NCT06105801


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