NCT01972386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

October 8, 2013

Last Update Submit

February 22, 2018

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Lymph Node Staging

    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)

Study Arms (1)

Spectrum Image Analysis

Device: Spectrum Image Analysis using a Linear Array Ultrasound Bronchoscope

Interventions

Spectrum Image Analysis using a Linear Array Ultrasound BronchoscopeDEVICE
Spectrum Image Analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 30, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

January 1, 2016

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

CA(1)