Spectrum Analysis in Ex-vivo Human Lungs
Spectrum Analysis of Endobronchial Ultrasound Radiofrequency of Lung Tumors in Ex-vivo Human Lungs
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Jul 2017
Shorter than P25 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2017
CompletedFirst Submitted
Initial submission to the registry
November 13, 2017
CompletedFirst Posted
Study publicly available on registry
November 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMay 4, 2018
May 1, 2018
10 months
November 13, 2017
May 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
To find the correlation of TS mode image findings with pathology by using lung tumor and lymph node samples.
Within an hour after resection
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
Study Arms (1)
Ex-Vivo
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Any patients scheduled for lobectomy of anatomical segmental resection for malignant lung tumors.
- years of age or older
You may not qualify if:
- Any patients with inability to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2017
First Posted
November 29, 2017
Study Start
July 12, 2017
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
May 4, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share
Plan on sharing data at the time of manuscript publication.