Lung Cancer
Conditions
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
Interventions
PROCEDUREEndobronchial ultrasound with transbronchial needle aspiration
Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration
PROCEDUREBronchoscopy
Participants will undergo Bronchoscopy
PROCEDURECryobiopsy
Participants will undergo Cryobiopsy
Sponsors
Vanderbilt-Ingram Cancer Center
Northwestern Medicine
Johns Hopkins University
Duke University
Medical University of South Carolina
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Histological disease subtyping | Up to 12 Months | Comparison of samples between arms for subtypes of lung malignancies (primary or metastatic) |
Countries
United States
Contacts
CONTACTVanderbilt-Ingram Services for Timely Access
PRINCIPAL_INVESTIGATORFabien Maldonado, MD
Vanderbilt University/Ingram Cancer Center
Outcome results
None listed