NCT02285426

Brief Summary

Videobronchoscopy is an essential diagnostic procedure for evaluation of the central airways and pivotal for the diagnosis and staging of lung cancer. Further technological improvements have resulted in high definition (HD+) images and advanced image enhancement technique (i-scan). An earlier study (NCT01676012) has indicated that HD+ bronchoscopy in combination with i-scan technology is superior to HD+WL (white light) for detecting endobronchial vascular changes. In this study we aim to correlate these vascular changes to histology and hypothesize that these vascular changes are related to (pre-) malignant changes and that the addition of i-scan is superior to HD+ WL.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
4 countries

4 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

Study Start

First participant enrolled

October 20, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2017

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

2.6 years

First QC Date

October 27, 2014

Last Update Submit

April 11, 2018

Conditions

Lungcancer

Keywords

i-scanhistology

Outcome Measures

Primary Outcomes (1)

  • positive predictive value of HD+ i-scan bronchoscopy for detecting (pre-) malignant lesions

    Determing the positive predictive value of HD+ i-scan bronchoscopy for vascular pattern detection .

    7 days

Secondary Outcomes (3)

  • correlation between endobronchial vascular patterns and histology

    7 days

  • interobserver variability for detecting vascular abnormalities

    3 - 12 months

  • impact of HD-bronchoscopy on clinical decision

    1-56 days

Study Arms (1)

suspected lungcancer

Patients will undergo a bronchoscopy with the Pentax EB1990i HD-bronchoscope investigating the entire bronchial tree. The HD+ bronchoscopy needs to be performed in a standardized way using 3 different imaging modes: 1. HD+bronchoscopy 2. HD+bronchoscopy + i-Scan 1 3. HD+bronchoscopy + i-Scan 2

Device: Pentax EB-1990i HD-bronchoscope guided biopsy

Interventions

Pentax EB-1990i HD-bronchoscope guided biopsyDEVICE

3 different types of bronchoscopy image settings will be used investigating the entire bronchial tree. When sites with abnormal or suspicious vascular patterns are detected meeting the criteria of abnormality \[visual scale adapted from Herth 2009 and Zaric 2013\] the investigator will change to a normal bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control.

suspected lungcancer

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with suspected or proven lung cancer are eligible if there is an indication for bronchoscopy. Eligible are patients with ASA physical status 1-3 and aged 18 years or older.

You may qualify if:

  • Patients with indication for diagnostic bronchoscopy for suspected or proven lung cancer.
  • ASA physical status 1-3.
  • Age 18 years or older.
  • Signed and dated patient informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ospedale Umberto I, Via Dante Alighieri n.1

Ravenna, RA, Italy

Location

RadboudUMC

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

St-Petersburg Research Institute of TB and Thoracic Surgery

Saint Petersburg, Russia

Location

Hospital Universitario Santa Lucia

Murcia, 30202, Spain

Location

Related Publications (1)

  • van der Heijden EHFM, Candoli P, Vasilev I, Messi A, Perez Pallares J, Yablonskii P, van der Vorm A, Schuurbiers OCJ, Hoefsloot W. Image enhancement technology in bronchoscopy: a prospective multicentre study in lung cancer. BMJ Open Respir Res. 2018 May 18;5(1):e000295. doi: 10.1136/bmjresp-2018-000295. eCollection 2018.

    PMID: 29862031DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

biopsy of sites with abnormal or suspicious vascular patterns

Study Officials

  • Erik HF van der Heijden, MD, PhD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 27, 2014

First Posted

November 7, 2014

Study Start

October 20, 2014

Primary Completion

June 5, 2017

Study Completion

June 5, 2017

Last Updated

April 12, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)NL(1)RU(1)ES(1)