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

NCT ID: NCT06105801

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-13
• Study Completion Date: 2028-10-31

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.

Detailed Description

Primary Objective:

• To evaluate the utility of transbronchial mediastinal cryobiopsy on its ability to improve the likelihood of acquiring tissue sufficient for next-generation sequencing (NGS).

Safety Endpoints:

• Pneumothorax within 7 days of procedure
• Moderate bleeding defined as controlled with bronchoscope, saline, or epinephrine
• Serious bleeding is defined as uncontrolled, leading to respiratory failure, need for transfusion, or cardiovascular instability
• Respiratory failure is defined as a new oxygen requirement or escalation in oxygen delivery within 7 days of procedure
• Unplanned hospitalization related to the procedure within 7 days of procedure
• Death

Exploratory Endpoints:

• The proportion of samples adequate for NGS testing
• The proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining
• Proportion of samples that are adequate for complete NGS library sequencing
• Estimated total number of tumor cells per H&E-stained slide
• Histological disease subtyping

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Endobronchial ultrasound with transbronchial needle aspiration

Intervention Type: PROCEDURE

Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration

Bronchoscopy

Intervention Type: PROCEDURE

Participants will undergo Bronchoscopy

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.

Group Type: EXPERIMENTAL

Endobronchial ultrasound with transbronchial needle aspiration

Intervention Type: PROCEDURE

Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration

Bronchoscopy

Intervention Type: PROCEDURE

Participants will undergo Bronchoscopy

Cryobiopsy

Intervention Type: PROCEDURE

Participants will undergo Cryobiopsy

Interventions

Endobronchial ultrasound with transbronchial needle aspiration

Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration

Intervention Type: PROCEDURE

Bronchoscopy

Participants will undergo Bronchoscopy

Intervention Type: PROCEDURE

Cryobiopsy

Participants will undergo Cryobiopsy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern Medicine

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Fabien Maldonado

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabien Maldonado, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University/Ingram Cancer Center

Locations

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vanderbilt-Ingram Services for Timely Access

Role: CONTACT

cip@vumc.org

800-811-8480

Facility Contacts

Vanderbilt-Ingram Service Services for Timely Access

Role: primary

cip@vumc.org

800-811-8480

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2023-08954

Identifier Type: REGISTRY

Identifier Source: secondary_id

VICC-VDTHO23177

Identifier Type: -

Identifier Source: org_study_id