A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Proportion of samples sufficient for next-generation sequencing testing
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Endobronchial ultrasound with transbronchial needle aspiration (Procedure)
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.
干预措施: Bronchoscopy (Procedure)
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.
干预措施: Endobronchial ultrasound with transbronchial needle aspiration (Procedure)
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.
干预措施: Bronchoscopy (Procedure)
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.
干预措施: Cryobiopsy (Procedure)
结局指标
主要结局
Proportion of samples sufficient for next-generation sequencing testing
时间窗: Up to 12 months
Comparison of samples between arms that meet sufficiency criteria for NGS
次要结局
- Proportion of samples that are adequate for complete NGS library sequencing(Up to 12 months)
- Histological disease subtyping(Up to 12 Months)
- Proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining(Up to 12 months)
- Estimated total number of tumor cells per H&E-stained slide(Up to 12 Months)
研究者
Fabien Maldonado
Professor of Medicine
Vanderbilt-Ingram Cancer Center