Vanderbilt-Ingram Cancer Center
Fabien Maldonado
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.
Lung Cancer
Endobronchial ultrasound with transbronchial needle aspiration
Bronchoscopy
Cryobiopsy
PHASE3
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
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 250 participants |
| Masking : | SINGLE |
| Primary Purpose : | DIAGNOSTIC |
| Official Title : | A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing |
| Actual Study Start Date : | 2024-09-13 |
| Estimated Primary Completion Date : | 2027-10-31 |
| Estimated Study Completion Date : | 2028-10-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232