A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Tennessee
Vanderbilt University/Ingram Cancer Center
RECRUITING
Nashville
Contact Information
Primary
Vanderbilt-Ingram Services for Timely Access
cip@vumc.org
800-811-8480
Time Frame
Start Date: 2024-09-13
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 250
Treatments
Active_comparator: EBUS-TBNA Group
The same needle gauge will be used for these participant to acquire the initial diagnosis on ROSE (either 21 or 22G). Using standard sampling techniques, the mass or LN will be penetrated with the needle as confirmed by ultrasound, and the needle will be passed back from the proximal to the distal ends of the node to obtain the samples for an adequate cell block.
Experimental: Transbronchial Mediastinal Cryobiopsy Group
The operator will switch to a flexible, single-use, 1.1 mm cryoprobe (Erbe 20402-401, Erbe, Tübingen, Germany) for these participants to obtain cryobiopsies. The operator will introduce the probe into the working channel of the EBUS bronchoscope. The cryoprobe will then be advanced toward the puncture site and inserted gently through the previous puncture site created by the initial EBUS-TBNA needle. The operator will confirm the placement of the probe via the EBUS image, and photo capture will be done. The cryo-probe will be activated and cooled for 3 seconds before retracting with the bronchoscope with the frozen biopsy tissue attached to the tip.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt-Ingram Cancer Center
Collaborators: Northwestern Medicine, Johns Hopkins University, Duke University

This content was sourced from clinicaltrials.gov