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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
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

November 13, 2017
November 29, 2017
May 4, 2018
July 12, 2017
May 1, 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03356743 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Spectrum Analysis in Ex-vivo Human Lungs
Spectrum Analysis of Endobronchial Ultrasound Radiofrequency of Lung Tumors in Ex-vivo Human Lungs
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.
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Lung Cancer
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.
Experimental: Ex-Vivo
Intervention: Device: Spectrum Analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
May 1, 2018
May 1, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT03356743
16-6177
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Plan on sharing data at the time of manuscript publication.
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Not Provided
University Health Network, Toronto
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP