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

Phase 3

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06105801
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

This is a multi-center, clinical trial evaluating the effect of adding transbronchial mediastinal cryobiopsy to EBUSTBNA 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 acquisition of tissue for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE of a mediastinal 8 lymph node or mass suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a transbronchial mediastinal cryobiopsy.

Detailed Description

Primary Objective:

- To evaluate the utility of adding transbronchial mediastinal cryobiopsy to endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) 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:

* 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

Study Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-30
• Study Start: 2024-09-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-25
• Primary Completion: 2027-10-31
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of samples sufficient for next-generation sequencing testing	Up to 12 months	Comparison of samples between arms that meet sufficiency criteria for NGS

Secondary Outcome Measures

Name	Time	Method
Proportion of samples that are adequate for complete NGS library sequencing	Up to 12 months	Comparison of samples between arms that meet sufficiency criteria and then are adequate for complete NGS library sequencing
Histological disease subtyping	Up to 12 Months	Comparison of samples between arms for subtypes of lung malignancies (primary or metastatic)
Proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining	Up to 12 months	Comparison of samples between arms that meet PD-1/PD-L1 adequacy
Estimated total number of tumor cells per H&E-stained slide	Up to 12 Months	Comparison of samples between arms of estimated tumor cells per H\&E-stained field

Trial Locations

Locations (1)

Vanderbilt University/Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States