TBNA vs EBUS-TBNA Plus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
- Conditions
- Lung Cancer
- Interventions
- Procedure: Endobronchial ultrasound with transbronchial needle aspirationProcedure: BronchoscopyProcedure: Cryobiopsy
- Registration Number
- NCT06105801
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- Brief Summary
This is a multi-center, clinical trial evaluating the effect of adding transbronchial mediastinal cryobiopsy to EBUSTBNA 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 acquisition of tissue for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE of a mediastinal 8 lymph node or mass suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a transbronchial mediastinal cryobiopsy.
- Detailed Description
Primary Objective:
- To evaluate the utility of adding transbronchial mediastinal cryobiopsy to endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) 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:
* 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transbronchial Mediastinal Cryobiopsy Group Endobronchial ultrasound with transbronchial needle aspiration The operator will switch to a flexible, single-use, 1.1 mm cryoprobe (Erbe 20402-401, Erbe, Tübingen, Germany) for these participants to obtain cryobiopsies. The operator will introduce the probe into the working channel of the EBUS bronchoscope. The cryoprobe will then be advanced toward the puncture site and inserted gently through the previous puncture site created by the initial EBUS-TBNA needle. The operator will confirm the placement of the probe via the EBUS image, and photo capture will be done. The cryo-probe will be activated and cooled for 3 seconds before retracting with the bronchoscope with the frozen biopsy tissue attached to the tip. Transbronchial Mediastinal Cryobiopsy Group Bronchoscopy The operator will switch to a flexible, single-use, 1.1 mm cryoprobe (Erbe 20402-401, Erbe, Tübingen, Germany) for these participants to obtain cryobiopsies. The operator will introduce the probe into the working channel of the EBUS bronchoscope. The cryoprobe will then be advanced toward the puncture site and inserted gently through the previous puncture site created by the initial EBUS-TBNA needle. The operator will confirm the placement of the probe via the EBUS image, and photo capture will be done. The cryo-probe will be activated and cooled for 3 seconds before retracting with the bronchoscope with the frozen biopsy tissue attached to the tip. EBUS-TBNA Group Endobronchial ultrasound with transbronchial needle aspiration The same needle gauge will be used for these participant to acquire the initial diagnosis on ROSE (either 21 or 22G). Using standard sampling techniques, the mass or LN will be penetrated with the needle as confirmed by ultrasound, and the needle will be passed back from the proximal to the distal ends of the node to obtain the samples for an adequate cell block. EBUS-TBNA Group Bronchoscopy The same needle gauge will be used for these participant to acquire the initial diagnosis on ROSE (either 21 or 22G). Using standard sampling techniques, the mass or LN will be penetrated with the needle as confirmed by ultrasound, and the needle will be passed back from the proximal to the distal ends of the node to obtain the samples for an adequate cell block. Transbronchial Mediastinal Cryobiopsy Group Cryobiopsy The operator will switch to a flexible, single-use, 1.1 mm cryoprobe (Erbe 20402-401, Erbe, Tübingen, Germany) for these participants to obtain cryobiopsies. The operator will introduce the probe into the working channel of the EBUS bronchoscope. The cryoprobe will then be advanced toward the puncture site and inserted gently through the previous puncture site created by the initial EBUS-TBNA needle. The operator will confirm the placement of the probe via the EBUS image, and photo capture will be done. The cryo-probe will be activated and cooled for 3 seconds before retracting with the bronchoscope with the frozen biopsy tissue attached to the tip.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Histological disease subtyping Up to 12 Months Comparison of samples between arms for subtypes of lung malignancies (primary or metastatic)
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
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
Trial Locations
- Locations (1)
Vanderbilt University/Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States