Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02285426
Recruitment Status : Completed
First Posted : November 7, 2014
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date October 27, 2014
First Posted Date November 7, 2014
Last Update Posted Date April 12, 2018
Actual Study Start Date October 20, 2014
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 4, 2014)
positive predictive value of HD+ i-scan bronchoscopy for detecting (pre-) malignant lesions [ Time Frame: 7 days ]
Determing the positive predictive value of HD+ i-scan bronchoscopy for vascular pattern detection .
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 4, 2014)
  • correlation between endobronchial vascular patterns and histology [ Time Frame: 7 days ]
    relate grading of detected vascular abnormalities with histology outcome of biopsies
  • interobserver variability for detecting vascular abnormalities [ Time Frame: 3 - 12 months ]
    compare bronchoscopist reported outcome to central review of obtained videos to determine interobserver variability
  • impact of HD-bronchoscopy on clinical decision [ Time Frame: 1-56 days ]
    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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title HD+ I-scan Bronchoscopy Vascular Abnormalities Detection Multicenter Study
Official Title 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
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
biopsy of sites with abnormal or suspicious vascular patterns
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.
Condition Lungcancer
Intervention 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.

Study Groups/Cohorts 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
Intervention: Device: Pentax EB-1990i HD-bronchoscope guided biopsy
Publications * van der Heijden EHFM, Candoli P, Vasilev I, Messi A, Pérez Pallarés 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 11, 2018)
134
Original Estimated Enrollment
 (submitted: November 4, 2014)
150
Actual Study Completion Date June 5, 2017
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy,   Netherlands,   Russian Federation,   Spain
Removed Location Countries Germany,   Turkey
 
Administrative Information
NCT Number NCT02285426
Other Study ID Numbers NL5012109114
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Radboud University
Study Sponsor Radboud University
Collaborators Not Provided
Investigators
Principal Investigator: Erik HF van der Heijden, MD, PhD Principal Investigator
PRS Account Radboud University
Verification Date April 2018