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

ConditionLung Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Endobronchial ultrasound with transbronchial needle aspiration
  • Bronchoscopy
  • Cryobiopsy

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Vanderbilt-Ingram Cancer Center

Lead sponsor

Northwestern Medicine

Collaborator

Johns Hopkins University

Collaborator

Duke University

Collaborator

Medical University of South Carolina

Collaborator

Virginia Commonwealth University

Collaborator