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EBUS/Spectrum Analysis

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ClinicalTrials.gov Identifier: NCT01972386
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
To evaluate the clinical benefit of spectrum analysis of endobronchial ultrasound images of lymph nodes during EBUS TBNA for lymph node staging in patients with lung cancer.

Condition or disease Intervention/treatment
Lung Cancer Device: Spectrum Image Analysis using a Linear Array Ultrasound Bronchoscope

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Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Spectrum Image Analysis of Lymph Nodes During Endobronchial Ultrasound-Guided (EBUS) Transbronchial Needle Aspiration (TBNA) in Patients With Lung Cancer
Study Start Date : September 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Spectrum Image Analysis Device: Spectrum Image Analysis using a Linear Array Ultrasound Bronchoscope



Primary Outcome Measures :
  1. Lymph Node Staging [ Time Frame: Pathology report will be completed as soon as possible after the procedure. (Within one year) ]
    The lymph node staging will be determined by the pathology report of the biopsy taken from the patients lymph node(s).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with lung cancer or suspected lung cancer who undergo EBUS TBNA for lymph node staging.
Criteria

Inclusion Criteria:

  • Ages 18 years or older
  • Patients with known or suspected lung cancer who require EBUS-TBNA for lymph node staging

Exclusion Criteria:

  • Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy
  • Inability to give informed consent
  • Patients who are pregnant

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): NCT01972386


Locations
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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01972386     History of Changes
Other Study ID Numbers: 12-5898-CE
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases