EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
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.
Lung
Phase III
Adults
Not Available
Not Available
Maldonado, Fabien
National
Vanderbilt University
08-12-2024
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Lesions on PET or CT concerning for primary or metastatic malignancy that are amenable to biopsy by linear EBUS
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)
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 less than 18 years old
Patient is known to be pregnant
Patient is known to be pregnant
Patient is known to be a prisoner
Patient is known to be a prisoner
Operator deems lesion is not safe to biopsy
Operator deems lesion is not safe to biopsy
Lesions on PET or CT concerning for primary or metastatic malignancy that are amenable to biopsy by linear EBUS
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)
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 less than 18 years old
Patient is known to be pregnant
Patient is known to be pregnant
Patient is known to be a prisoner
Patient is known to be a prisoner
Operator deems lesion is not safe to biopsy
Operator deems lesion is not safe to biopsy
