Spectrum Analysis in Ex-vivo Human Lungs
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|ClinicalTrials.gov Identifier: NCT03356743|
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : May 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Device: Spectrum Analysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Spectrum Analysis of Endobronchial Ultrasound Radiofrequency of Lung Tumors in Ex-vivo Human Lungs|
|Actual Study Start Date :||July 12, 2017|
|Actual Primary Completion Date :||May 1, 2018|
|Actual Study Completion Date :||May 1, 2018|
Device: Spectrum Analysis
The ultrasound probe will be placed on the lung surface in several different directions to obtain the cross section with maximum diameter. Three spectral parameters including midband-fit (dB), intercept (dB), and slope (dB/MHz) will be calculated and compared between the tumor and the lung.
- To analyze the relationship of three spectral features of the radiofrequency of lung tumors in ex-vivo human lungs. [ Time Frame: Within an hour after resection. ]From obtained ultrasound images, a linear regression line is quantified, and three ultrasonic spectral parameters including Midband-fit, Intercept, and Slope are calculated.
- To find the correlation of TS mode image findings with pathology by using lung tumor and lymph node samples. [ Time Frame: Within an hour after resection ]After evaluation, the actual tumor size and histological diagnosis will be determined. Differences between US image and pathological morphology will be determined by using HE and Immunohistochemistry (IHC) slides of lung tumor, the investigators will evaluate comparison of nucleus size in each tissue and the spectral parameters in each region of interest.
- To clarify the feasibility of using the conventional EBUS scope to visualize solitary pulmonary nodules in an ex-vivo human lung. [ Time Frame: Within an hour after resection ]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, visualization of the tumor will be evaluated to see the difference in ultrasound images between deflated and inflated lung.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356743
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|