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
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