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Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS)

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ClinicalTrials.gov Identifier: NCT03814824
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
NinePoint Medical
Information provided by (Responsible Party):
Northwell Health

Brief Summary:
This is a prospective randomized clinical trial examining how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric laser endomicroscopy).

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Without Dysplasia Barrett's Esophagus With Dysplasia Barrett's Esophagus With Low Grade Dysplasia Barrett's Esophagus With High Grade Dysplasia Barrett's Esophagus With Dysplasia, Unspecified Diagnostic Test: IRIS (Intelligent real-time image segmentation) Diagnostic Test: VLE (Volumetric laser endomicroscopy) Not Applicable

Detailed Description:

Patients will undergo a VLE exam with and without IRIS per the standard of care. All patients regardless of the study participation in this study would receive VLE with and without IRIS clinically. They will be randomized into VLE without IRIS first vs VLE with IRIS first. The BUDDY Randomization System, provided for use by the Northwell Health Biostatistics Unit, will be used for this. Randomization will be stratified based on prior diagnosis of dysplasia. The order in which the patient is randomized to will be recorded on the case report form. There will be concealed allocation as the study coordinator performing the randomization will not know the order of the next allocation.

Both VLE and IRIS imaging are being performed as standard of care. However, randomization of the order allows for comparison of the two. Regions of interest (ROI) will be recorded using a full scan and recorded on the case report form. The time to identification of ROIs will also be recorded. Each group will then cross over such that the VLE without IRIS group will then have IRIS turned on. ROI will then be recorded for each group based on full scans. A consensus ROI will be recorded based on the two exams. Only one ROI per centimeter will be allowed to avoid overlapping of laser marks. In addition, VLE without IRIS and IRIS marks within 75 frames of each other or 2 hours (on a clock face orientation) will be considered the same target.

Laser marking will then be performed. A double laser mark will be applied to all IRIS ROIs. A single laser mark will be applied to VLE ROIs. Targeted biopsies will be taken of all laser marks and placed in separate biopsy jars. Biopsies will be taken in between the laser marks for double laser marked areas. For single laser marks, biopsies will be taken on either side of the laser mark. Resection of visible lesions will then occur per standard of care (if present) followed by random biopsies of the segment. Random biopsies are pinch biopsies every 1 cm the length of the Barrett's in a 4 quadrant fashion per gastrointestinal society guidelines. There are no additional research biopsies being performed outside this study. The targeted biopsies are based on the VLE features that are suspicious for dysplasia and thus standard of care. The other biopsies being performed here are random biopsies which are also being performed for standard of care. Biopsied samples will be stored per standard of care procedures per the pathology department. They will not be stored for future research purposes.

Following each procedure, the physician will be asked a series of Likert Scale questions to assess the utility of IRIS in that procedure, including how it impacts their confidence in image interpretation, their ability to assimilate data more easily and quickly, and their overall perception of the technology.

Although, the VLE with IRIS and VLE without IRIS are being performed as standard of care, all adverse events will be recorded and reported to the IRB.

All data will be entered into a central encrypted REDCap database.

Expert pathologists who specialize in gastrointestinal pathology will read the histology. A second gastrointestinal pathologist will confirm any histologic diagnosis of dysplasia. This is the standard of care at Northwell Health and academic medical centers per gastrointestinal society guidelines.

All procedures (upper endoscopy, volumetric laser endomicroscopy, and IRIS enhanced VLE) will be performed as standard of care. The prospective data collection and initial randomization will be the research component. All data collected will be de-identified before being transferred into a database. This will be kept in a safe place that is only accessible to the research team.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS): a Multi-center Randomized Prospective Study
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Active Comparator: VLE without IRIS, followed by VLE with IRIS
VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.
Diagnostic Test: IRIS (Intelligent real-time image segmentation)
IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.

Diagnostic Test: VLE (Volumetric laser endomicroscopy)
VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.

Active Comparator: VLE with IRIS, followed by VLE without IRIS
VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.
Diagnostic Test: IRIS (Intelligent real-time image segmentation)
IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.

Diagnostic Test: VLE (Volumetric laser endomicroscopy)
VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.




Primary Outcome Measures :
  1. Time for image interpretation [ Time Frame: During the procedure ]
    Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of Barrett's will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.

  2. Biopsy yield [ Time Frame: During the procedure ]
    Biopsy yield (in terms of dysplasia present versus not present) of IRIS biopsies (double laser mark) will be compared to VLE without IRIS biopsies (single laser mark) and random biopsies (taken every 1cm in a four quadrant fashion throughout the length of the Barrett's).

  3. Number of biopsies [ Time Frame: at time of initial study procedure ]
    Total number of targeted and random biopsies taken during each procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older at the time of informed consent
  • Barrett's esophagus greater than 2 cm in length
  • Undergoing a scheduled upper endoscopy with VLE exam for surveillance as standard of care

Exclusion Criteria:

  • Less than 18 years old at the time of informed consent
  • Unable to provide written informed consent
  • Esophageal stenosis/stricture preventing VLE
  • Esophagitis
  • Severe medical comorbidities preventing endoscopy
  • Pregnancy
  • Uncontrolled coagulopathy

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): NCT03814824


Contacts
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Contact: Arvind Trindade, MD 718-470-7997 atrindade@northwell.edu
Contact: Molly Stewart, BS 516-600-1443 mstewart8@northwell.edu

Locations
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United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Molly Stewart, BS    516-600-1443    mstewart8@northwell.edu   
Principal Investigator: Arvind Trindade, MD         
Sponsors and Collaborators
Northwell Health
NinePoint Medical
Investigators
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Principal Investigator: Arvind Trindade, MD Northwell Health

Publications:

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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT03814824     History of Changes
Other Study ID Numbers: 18-0963
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Northwell Health:
VLE
Volumetric laser endomicroscopy
IRIS
Intelligent real-time image segmentation
Barrett's Esophagus

Additional relevant MeSH terms:
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Hyperplasia
Barrett Esophagus
Pathologic Processes
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases