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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02665078
Study type Observational
Source University Health Network, Toronto
Contact
Status Completed
Phase N/A
Start date January 2015
Completion date November 2015

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