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

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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

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.

Condition or disease Intervention/treatment
Lungcancer 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.


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Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : October 20, 2014
Actual Primary Completion Date : June 5, 2017
Actual Study Completion Date : June 5, 2017

Resource links provided by the National Library of Medicine


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:

  1. HD+bronchoscopy
  2. HD+bronchoscopy + i-Scan 1
  3. 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.





Primary Outcome Measures :
  1. 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 .


Secondary Outcome Measures :
  1. correlation between endobronchial vascular patterns and histology [ Time Frame: 7 days ]
    relate grading of detected vascular abnormalities with histology outcome of biopsies

  2. 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

  3. 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


Biospecimen Retention:   Samples Without DNA
biopsy of sites with abnormal or suspicious vascular patterns


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285426


Locations
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Italy
Ospedale Umberto I, Via Dante Alighieri n.1
Ravenna, RA, Italy
Netherlands
RadboudUMC
Nijmegen, Gelderland, Netherlands, 6500 HB
Russian Federation
St-Petersburg Research Institute of TB and Thoracic Surgery
Saint-Petersburg, Russian Federation
Spain
Hospital Universitario Santa Lucia
Murcia, Spain, 30202
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Erik HF van der Heijden, MD, PhD Principal Investigator

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02285426     History of Changes
Other Study ID Numbers: NL5012109114
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Radboud University:
i-scan
histology

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases