Spectrum Analysis in Ex-vivo Human Lungs

Lung Cancer Clinical Trial

Official title:

Spectrum Analysis of Endobronchial Ultrasound Radiofrequency of Lung Tumors in Ex-vivo Human Lungs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356743
• Other study ID #: 16-6177
• Status: Completed
• Phase: N/A
• Start date: July 12, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will analyze spectral features of the radiofrequency of lung tumors in ex-vivo human lungs. The resected specimens will be evaluated using the spectrum analysis to determine the localization rate of the targets. Ultrasound measurement and images will be used for correlation of TS mode image findings with pathology by using HE and IHC slides of lung tumor and lymph node.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patients scheduled for lobectomy of anatomical segmental resection for malignant lung tumors.

• 18 years of age or older

Exclusion Criteria:

• Any patients with inability to give informed consent.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To analyze the relationship of three spectral features of the radiofrequency of lung tumors in ex-vivo human lungs.	From obtained ultrasound images, a linear regression line is quantified, and three ultrasonic spectral parameters including Midband-fit, Intercept, and Slope are calculated.	Within an hour after resection.
Secondary	To find the correlation of TS mode image findings with pathology by using lung tumor and lymph node samples.	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.	Within an hour after resection
Secondary	To clarify the feasibility of using the conventional EBUS scope to visualize solitary pulmonary nodules in an ex-vivo human lung.	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.	Within an hour after resection