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

NCT06105801 | Recruiting Phase 4 DMC

• 2 other identifiers: VICC-VDTHO23177NCI-2023-08954
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of samples sufficient for next-generation sequencing testing

  Comparison of samples between arms that meet sufficiency criteria for NGS

  Up to 12 months

Secondary Outcomes (4)

• Proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining

  Up to 12 months

• Proportion of samples that are adequate for complete NGS library sequencing

  Up to 12 months

• Estimated total number of tumor cells per H&E-stained slide

  Up to 12 Months

• Histological disease subtyping

  Up to 12 Months

Study Arms (2)

EBUS-TBNA Group

ACTIVE COMPARATOR

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.

Procedure: Endobronchial ultrasound with transbronchial needle aspiration; Procedure: Bronchoscopy

Transbronchial Mediastinal Cryobiopsy Group

EXPERIMENTAL

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.

Procedure: Endobronchial ultrasound with transbronchial needle aspiration; Procedure: Bronchoscopy; Procedure: Cryobiopsy

Interventions

Endobronchial ultrasound with transbronchial needle aspiration PROCEDURE

Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration

EBUS-TBNA Group; Transbronchial Mediastinal Cryobiopsy Group

Bronchoscopy PROCEDURE

Participants will undergo Bronchoscopy

EBUS-TBNA Group; Transbronchial Mediastinal Cryobiopsy Group

Cryobiopsy PROCEDURE

Participants will undergo Cryobiopsy

Transbronchial Mediastinal Cryobiopsy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern Medicine: collaborator
• Johns Hopkins University: collaborator
• Duke University: collaborator
• Medical University of South Carolina: collaborator
• Virginia Commonwealth University: collaborator
• Vanderbilt-Ingram Cancer Center: lead

Study Sites (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Fabien Maldonado, MD

  Vanderbilt University/Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanderbilt-Ingram Services for Timely Access

CONTACT

800-811-8480; cip@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 30, 2023
• Study Start: September 13, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)