RecruitingRecruiting
EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
NCT06105801 · Vanderbilt-Ingram Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
About this study
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
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
Study design
Enrollment target: 250 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-09-13
Estimated completion: 2028-10-31
Last updated: 2026-02-02
Interventions
Procedure: Endobronchial ultrasound with transbronchial needle aspirationProcedure: BronchoscopyProcedure: Cryobiopsy
Primary outcomes
- • Proportion of samples sufficient for next-generation sequencing testing (Up to 12 months)
Sponsor
Vanderbilt-Ingram Cancer Center · other
With: Northwestern Medicine, Johns Hopkins University, Duke University, Medical University of South Carolina, Virginia Commonwealth University
Contacts & investigators
ContactVanderbilt-Ingram Services for Timely Access · contact · cip@vumc.org · 800-811-8480
InvestigatorFabien Maldonado, MD · principal_investigator, Vanderbilt University/Ingram Cancer Center
All locations (1)
Vanderbilt University/Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States