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Recruiting NCT06105801

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

Phase IV Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endobronchial ultrasound with transbronchial needle aspiration, Bronchoscopy, Cryobiopsy.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing

Overview

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

Interventions

  • Procedure Endobronchial ultrasound with transbronchial needle aspiration
    Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration
  • Procedure Bronchoscopy
    Participants will undergo Bronchoscopy
  • Procedure Cryobiopsy
    Participants will undergo Cryobiopsy

Primary outcome measures

  • Proportion of samples sufficient for next-generation sequencing testing [Time frame: Up to 12 months]
Secondary outcome measures (4)
  • Proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining [Time frame: Up to 12 months]
  • Proportion of samples that are adequate for complete NGS library sequencing [Time frame: Up to 12 months]
  • Estimated total number of tumor cells per H&E-stained slide [Time frame: Up to 12 Months]
  • Histological disease subtyping [Time frame: Up to 12 Months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Vanderbilt University/Ingram Cancer Center — Nashville

Identifiers

NCT: NCT06105801 · VICC-VDTHO23177 · NCI-2023-08954

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗