META-Gen: TBNA vs EBUS-TBNA Plus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: EBUS-TBNA Group 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. The minimum number of cell passes to obtain a cell block will be set at three. |
Procedure: Endobronchial ultrasound with transbronchial needle aspiration
Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration
Procedure: Bronchoscopy
Participants will undergo Bronchoscopy
|
| Experimental: Transbronchial Mediastinal Cryobiopsy Group 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. The minimum number of freeze attempts to obtain a cell block will be set at three. |
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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Mediastinal lesion (lymph node or mass) on endobronchial ultrasound (EBUS) and/or PET/CT concerning for primary or metastatic malignancy
-
Malignant cells present on rapid on-site cytological evaluation (ROSE)
Exclusion Criteria:
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Patient is known to be less than 18 years old
-
Patient is known to be pregnant
-
Patient is known to be a prisoner
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Operator deems lesion is not safe to biopsy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Vanderbilt-Ingram Cancer Center
Investigators
- Principal Investigator: Fabien Maldonado, MD, Vanderbilt University/Ingram Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VICC-VDTHO23177
- NCI-2023-08954