NCT02906280

Brief Summary

EBUS-TBNA is often the sole diagnostic test applied in patients with stage IV lung cancer. A limitation of the TBNA needle when using a 22 Gauge needle is the limited ability to procure adequate histological samples. Although a larger 19 Ga needle can procure histological samples as demonstrated by the conventional 19 Ga needle, published data are not existing with respect to molecular diagnostics. A new nitinol-based 19 Ga needle has been developed for EBUS-TBNA. Given the frequent usage of 22 Ga needles for molecular diagnostics and the recent technical advancements in 19 Ga needle technology, we conduct a RCT to compare the performance of both needle types.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

May 27, 2016

Last Update Submit

September 19, 2016

Conditions

Lung Neoplasm

Keywords

EBUS-TBNA

Outcome Measures

Primary Outcomes (1)

  • Tissue core

    Descriptive tissue characteristics of tumor sample

    14 months

Secondary Outcomes (3)

  • Tumor cellularity per area of diagnostic tissue

    14 months

  • Quantity of DNA extracted

    14 months

  • Success rate of Next Generation Sequencing

    14 months

Study Arms (2)

19 Ga EBUS-TBNA needle

EXPERIMENTAL

needle aspiration by a flexible 19 Ga needle (Olympus)

Device: EBUS-TBNA needle

22 Ga EBUS-TBNA needle

ACTIVE COMPARATOR

needle aspiration by a 22 Ga needle (Olympus)

Device: EBUS-TBNA needle

Interventions

EBUS-TBNA needleDEVICE

tissue sampling

19 Ga EBUS-TBNA needle22 Ga EBUS-TBNA needle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (suspected) stage IV lung carcinoma identified on spiral computed tomography scan
  • requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis

You may not qualify if:

  • uncontrolled coagulopathy
  • tracheal stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals KU Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Christophe Dooms

CONTACT

christophe.dooms@uzleuven.be

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 27, 2016

First Posted

September 20, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

September 20, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)