An observational study in Lung Cancer, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-26.
Sponsored by University Health Network, Toronto · Observational
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.
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.
188 studies on the registry are indexed under Multiple Pulmonary Nodules; 60 are open to participants now.
This study's enrollment of 25 is below the median of 255 across 87 observational studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Any patients scheduled for lobectomy of anatomical segmental resection for malignant lung tumors.
Exclusion Criteria:
Patients who undergo lobectomy or an anatomical segmental resection for malignant lung tumors will be enrolled in the study. After lung resection, 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). 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 HE slides of lung tumor.
Other: Thoracoscopic Ultrasound
We will evaluate the resected specimen using the XLTF-UC180 in the operating room (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.
Comparison of XLTF-UC180 Nodule Measurement with pathological morphology
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
Time frame: 2 Years
Plan to share: Yes — Through Publication
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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto