Clinical trial NCT06105801: EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
Official title: A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lung Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: Northwestern Medicine
name: Johns Hopkins University
name: Duke University
First posted: 2023-10-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Proportion of samples sufficient for next-generation sequencing testing
timeFrame: Up to 12 months
Secondary outcomes:
measure: Proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining
timeFrame: Up to 12 months
measure: Proportion of samples that are adequate for complete NGS library sequencing
timeFrame: Up to 12 months
measure: Estimated total number of tumor cells per H&E-stained slide
timeFrame: Up to 12 Months
measure: Histological disease subtyping
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University/Ingram Cancer Center
name: Fabien Maldonado, MD
role: PRINCIPAL_INVESTIGATOR
References: