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临床试验/NCT02665078
NCT02665078已完成不适用

Feasibility of a Minimally Invasive Thoracoscopic Ultrasound for Localization of Pulmonary Nodules Using Resected Human Lungs

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Comparison of XLTF-UC180 Nodule Measurement with pathological morphology

研究概览

简要总结

The ex-vivo lung will be evaluated by XLTF-UC180 for localization of the tumor. The ultrasound probe will be put on the lung surface in several different directions to obtain the cross section with maximum diameter. The ultrasound image with size measurement of the tumor will be recorded using an ultrasound scanner (EU-Y0008, OLYMPUS MEDICALSYSTEMS CORP., Tokyo, Japan). Next, the bronchial stump of the specimen will be opened and a small sized endotracheal tube will be inserted to inflate and deflate the lung. After inflation of the lung, the tumor will be evaluated by XLTF-UC180 to see the difference in ultrasound images between deflated and inflated lung. After ultrasound evaluation, the specimen will be delivered directly to the pathology laboratory and the actual tumor size and histological diagnosis will be determined. In addition, we will evaluate the differences between US image and pathological morphology using HE slides of lung tumor. We will work together with the surgical team to confirm sign off of specimens.

详细描述

This is a single center clinical trial. Forty patients (sufficient for an initial evaluation) scheduled for a lobectomy or an anatomical segmental resection for malignant lung tumors will be enrolled in the study. After lung resection, the lung will be placed on a surgical table in a similar position to the in-vivo situation in the Image Guided Therapeutic operating room (GTx-OR) within Toronto General Hospital. The lung will be evaluated by XLTF-UC180 for localization of the tumor. The ultrasound probe will be put on the lung surface in several different directions to obtain the cross section with maximum diameter. The ultrasound image with size measurement of the tumor will be recorded using an ultrasound scanner (EU-Y0008, OLYMPUS MEDICALSYSTEMS CORP., Tokyo, Japan). Next, the bronchial stump of the specimen will be opened and a small sized endotracheal tube will be inserted to inflate and deflate the lung. After inflation of the lung, the tumor will be evaluated by XLTF-UC180 to see the difference in ultrasound images between deflated and inflated lung. After ultrasound evaluation, the specimen will be delivered directory to the pathology laboratory and the actual tumor size and histological diagnosis will be determined. In addition, we will evaluate the differences between US image and pathological morphology using Hemotoxylin and Eosin (HE) slides of lung tumor. We will work together with the surgical team to confirm sign off of specimens.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patients scheduled for lobectomy of anatomical segmental resection for malignant lung tumors.
  • 18 Years of age and older

排除标准

  • Any patients with inability to give informed consent

结局指标

主要结局

Comparison of XLTF-UC180 Nodule Measurement with pathological morphology

时间窗: 2 Years

The primary objective of this study is to demonstrate the feasibility of thoracoscopic ultrasound for localization of pulmonary nodules in ex-vivo human lungs. We will evaluate the resected specimen using the XLTF-UC180 in the GTx-OR to determine the localization rate of the targets. Ultrasound measurement and images will be compared to the actual size of the tumor and pathological morphology using HE slides of lung tumor to determine the correlation between those variables. The tumor depth from the lung surface will be also collected to clarify the maximum depth to which the ultrasound can visualize

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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