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Spectrum Analysis in Ex-vivo Human Lungs

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ClinicalTrials.gov Identifier: NCT03356743
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: Spectrum Analysis Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Spectrum Analysis of Endobronchial Ultrasound Radiofrequency of Lung Tumors in Ex-vivo Human Lungs
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources


Intervention Details:
    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.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Kimberley Hudson 416-581-7486 kimberley.hudson@uhn.ca
Contact: Judy McConnell 416-581-7486 judy.mcconnell@uhn.ca

Locations
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Kimberley Hudson    416-581-7486    kimberley.hudson@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03356743     History of Changes
Other Study ID Numbers: 16-6177
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Plan on sharing data at the time of manuscript publication.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:
lobectomy