EBUS/Spectrum Analysis

February 22, 2018 updated by: University Health Network, Toronto

Spectrum Image Analysis of Lymph Nodes During Endobronchial Ultrasound-Guided (EBUS) Transbronchial Needle Aspiration (TBNA) in Patients With Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with lung cancer or suspected lung cancer who undergo EBUS TBNA for lymph node staging.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Pathology report will be completed as soon as possible after the procedure. (Within one year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 30, 2013

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-5898-CE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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