Recruiting

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

Sponsor:

Vanderbilt-Ingram Cancer Center

Code:

NCT06105801

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endobronchial ultrasound with transbronchial needle aspiration

Bronchoscopy

Cryobiopsy

Study Details

Brief 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.

Conditions

Lung Cancer

Study ID

NCT06105801

Start date

Sep 13, 2024

Status verified date

Jan, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Endobronchial ultrasound with transbronchial needle aspiration

Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration

Bronchoscopy

Participants will undergo Bronchoscopy

Cryobiopsy

Participants will undergo Cryobiopsy

Primary outcome measure

Proportion of samples sufficient for next-generation sequencing testing [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Vanderbilt-Ingram Services for Timely Access

800-811-8480 cip@vumc.org

Locations

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Vanderbilt-Ingram Service Services for Timely Access

800-811-8480 cip@vumc.org

Principal Investigator:

Fabien Maldonado, MD

More Information

Sponsor

Vanderbilt-Ingram Cancer Center

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center on 2026-02-02.