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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-08954 | Registry Identifier | NCI, Clinical Trials Reporting Program |
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| Name | Class |
|---|---|
| Northwestern Medicine | OTHER |
| Johns Hopkins University | OTHER |
| Duke University | OTHER |
| Medical University of South Carolina |
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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.
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:
Exploratory Endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS-TBNA Group | Active Comparator | 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. |
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| Transbronchial Mediastinal Cryobiopsy Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endobronchial ultrasound with transbronchial needle aspiration | Procedure | Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of samples sufficient for next-generation sequencing testing | Comparison of samples between arms that meet sufficiency criteria for NGS | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining | Comparison of samples between arms that meet PD-1/PD-L1 adequacy | Up to 12 months |
| Proportion of samples that are adequate for complete NGS library sequencing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanderbilt-Ingram Services for Timely Access | Contact | 800-811-8480 | cip@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Fabien Maldonado, MD | Vanderbilt University/Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University/Ingram Cancer Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 10, 2023 | Aug 29, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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| OTHER |
| Virginia Commonwealth University | OTHER |
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| Bronchoscopy | Procedure | Participants will undergo Bronchoscopy |
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| Cryobiopsy | Procedure | Participants will undergo Cryobiopsy |
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Comparison of samples between arms that meet sufficiency criteria and then are adequate for complete NGS library sequencing
| Up to 12 months |
| Estimated total number of tumor cells per H&E-stained slide | Comparison of samples between arms of estimated tumor cells per H&E-stained field | Up to 12 Months |
| Histological disease subtyping | Comparison of samples between arms for subtypes of lung malignancies (primary or metastatic) | Up to 12 Months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |