HD+ I-scan Bronchoscopy Vascular Abnormalities Detection Multicenter Study (i-scan)

A Multicenter Study Evaluating the Diagnostic Value for Vascular Abnormalities of High Definition Bronchoscopy When Combined With I-scan Imaging Technology Compared to High Defintion Bronchoscopy Alone

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.

Study Overview

• Status: Completed
• Conditions: Lungcancer
• Intervention / Treatment: Device: Pentax EB-1990i HD-bronchoscope guided biopsy

Detailed Description

Patients will undergo a bronchoscopy with Pentax EB1990i HD-bronchoscope in combination with Pentax EPKi series videoprocessor investigating the entire bronchial tree. Bronchoscopy will be performed by an experienced chest physician under local anaesthesia use and type of sedation following local protocol. Bronchoscopy will be performed in a standardized order using three different imaging modes. The order of the different modes will be randomized to avoid induced scope and / or cough lesion bias. High definition digital videos will be made from all procedures without in screen patient identification, but using a study code. The three imaging modes used in this study are: HD+, HD+ surface enhancement (SE, i-scan1) and HD+ surface enhancement and tone enhancement (TE-c, i-scan2).

When sites with abnormal or suspicious vascular patterns are detected the investigator grade these findings using a visual classification scale [adapted from Herth JTO 2009 & Zaric Med Oncol 2013] and change to a regular bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control. Finally any other indicated procedures will be performed at the discretion of the local investigator.

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• Italy
  • RA
    • Ravenna, RA, Italy
      • Ospedale Umberto I, Via Dante Alighieri n.1
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboudumc
• Russian Federation
  • Saint-Petersburg, Russian Federation
    • St-Petersburg Research Institute of TB and Thoracic Surgery
• Spain
  • Murcia, Spain, 30202
    • Hospital Universitario Santa Lucía

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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: HD+bronchoscopy; HD+bronchoscopy + i-Scan 1; HD+bronchoscopy + i-Scan 2

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between endobronchial vascular patterns and histology	relate grading of detected vascular abnormalities with histology outcome of biopsies	7 days
interobserver variability for detecting vascular abnormalities	compare bronchoscopist reported outcome to central review of obtained videos to determine interobserver variability	3 - 12 months
impact of HD-bronchoscopy on clinical decision	interview based evaluation to investigate whether the use of of i-scan technology and or the outcome of study-detected vascular sites changed the clinical approach or follow-up plan	1-56 days

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Erik HF van der Heijden, MD, PhD, Principal Investigator

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2014
• Primary Completion (Actual): June 5, 2017
• Study Completion (Actual): June 5, 2017

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 7, 2014

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: i-scan; histology
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: NL5012109114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No