NCT02488928

Brief Summary

EBUS elastography is a method to determine stiffness of lymph nodes, based on the minute deformation of the node by the beating heart. Whether EBUS elastography may further increase the sensitivity to predict the presence or absence of malignancy is unclear. We suggest to use EBUS elastography strain pattern analysis for this assessment and correlate these measurements with the final pathology outcome to determine NPV, PPV, sensitivity and specificity of this analysis to predict the presence or absence of malignancy in patients with (suspected) lung cancer in a prospectively obtained observational cohort study.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
327

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
3 countries

7 active sites

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

First Submitted

Initial submission to the registry

June 19, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

December 16, 2019

Status Verified

May 1, 2018

Enrollment Period

3 years

First QC Date

June 19, 2015

Last Update Submit

December 13, 2019

Conditions

Lung Cancer

Keywords

NSCLCEBUSelastographypredictive valuestrain

Outcome Measures

Primary Outcomes (1)

  • stiffness of lymph nodes

    stiffness/strain is a relative measure and has therefor no units

    participants will be followed for the duration of hospital stay, an expected average of 4 hours

Eligibility Criteria

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

Patients with suspected or proven lung cancer are eligible if there is an indication for EBUS, EUS or combined EBUS and EUSb (single scope, EUS with EBUS scope). Eligible are patients with no contra-indications for EBUS.

You may qualify if:

  • Patients with indication for diagnostic or staging EBUS procedure for suspected or proven lung cancer.
  • ASA physical status 1-3.
  • Age 18 years or older.

You may not qualify if:

  • Bleeding disorders.
  • Contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarol, warfarin, therapeutic dose of low molecular weight heparines or clopidrogel).
  • Known allergy for lidocaine.
  • Uncontrolled pulmonary hypertension.
  • Recent and/or uncontrolled cardiac disease.
  • Compromised upper airway (eg concomitant head and neck cancer or central airway stenosis for any reason).
  • Prior radiotherapy treatment involving the central airways
  • ASA classification greater than or equal to 4.
  • Pregnancy.
  • Inability to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Rigshospitalet

Copenhagen, Dk 2100, Denmark

Location

Interventional Pulmonology Unit Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliera Universitaria di Careggi

Florence, 50100, Italy

Location

Ausl Modena - Ospedale Santa Maria Bianca

Modena, 41037, Italy

Location

Pesaro-Fano Hospital

Pesaro, Italy

Location

RadboudUMC

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Lung NeoplasmsSprains and Strains

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesWounds and Injuries

Study Officials

  • Erik van der Heijden, MD, PhD

    chest physician

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 19, 2015

First Posted

July 2, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2018

Study Completion

April 1, 2019

Last Updated

December 16, 2019

Record last verified: 2018-05

Locations

IT(4)NL(2)DK(1)