Spectrum Analysis in Ex-vivo Human Lungs

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Device: Spectrum Analysis

• Registration Number: NCT03356743
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-12
• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-29
• Status Verified: 2018-05
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ex-Vivo	Spectrum Analysis	-

Primary Outcome Measures

Name	Time	Method
To analyze the relationship of three spectral features of the radiofrequency of lung tumors in ex-vivo human lungs.	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.

Secondary Outcome Measures

Name	Time	Method
To find the correlation of TS mode image findings with pathology by using lung tumor and lymph node samples.	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.	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.

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada