Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
Primary Purpose
Gastrointestinal Disease, Gastrointestinal Dysfunction
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biopsy imaged by Optical imaging device.
Sponsored by
About this trial
This is an interventional device feasibility trial for Gastrointestinal Disease focused on measuring OCT, Optical Coherence Tomography, Biopsy, GI disease, Endoscopy screening, Endoscopic Screening
Eligibility Criteria
Inclusion Criteria:
• Scheduled for an elective esophagoduodenoscopy and/or colonoscopy
Exclusion Criteria:
• According to standard of care at MGH endoscopy department.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Development of novel optical imaging technologies
Arm Description
Consented participants will allow their endoscopist to collect 3 additional biopsies from the participants. These biopsies will be used to develop our imaging techniques at our lab. We will use the standard of care histology images from the endoscopy procedure as a control comparison.
Outcomes
Primary Outcome Measures
Device Feasibility based on image quality and presence of microscopic features
The feasibility will be determined by at least one of the following parameters: 1) assessing image adequacy (resolution, contrast, etc.) qualitatively, 2) confirming that microscopic features observed in the images are also seen by correlative histopathology, 3) ability to develop preliminary criteria or algorithms based on image-histopathology matches.
Secondary Outcome Measures
Full Information
NCT ID
NCT04565704
First Posted
August 11, 2020
Last Updated
January 12, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04565704
Brief Title
Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
Official Title
Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 25, 2016 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
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
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To develop novel optical imaging technologies for use as a non-destructive and minimally invasive tool for detection and diagnosis of various diseases that affect the gastrointestinal system.
Detailed Description
The investigators have previously developed optical imaging systems that have been able to provide highly detailed images of tissue structures in multiple application areas including Cardiology, Gastroenterology, and Pulmonology. They are looking to continue the advancement of these various technologies under development.
The population will include subjects who are undergoing elective esophagogastroduodenoscopy with biopsy, colonoscopy with biopsy, and/or endo-mucosal resection.The endoscopist will take no more than 3 biopsies in addition to the standard of care biopsies.
The study will be optical imaging of the ex vivo GI specimens that are being collected. Specimens will be collected for research purposes only. Offline analysis of the samples will be performed, and optical imaging findings will be correlated with the pathology findings. This will require review of the medical record to link the findings of the imaging with the pertinent medical information. Samples will be de-identified and subjects will be assigned a unique number. The tissues will be placed in marked containers labeled "for research purposes only". The samples collected will be brought to the Tearney Research Laboratory for imaging and processing. The Optical imaging of the tissue samples will not affect the standard of care procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Disease, Gastrointestinal Dysfunction
Keywords
OCT, Optical Coherence Tomography, Biopsy, GI disease, Endoscopy screening, Endoscopic Screening
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Development of novel optical imaging technologies
Arm Type
Experimental
Arm Description
Consented participants will allow their endoscopist to collect 3 additional biopsies from the participants. These biopsies will be used to develop our imaging techniques at our lab. We will use the standard of care histology images from the endoscopy procedure as a control comparison.
Intervention Type
Device
Intervention Name(s)
Biopsy imaged by Optical imaging device.
Primary Outcome Measure Information:
Title
Device Feasibility based on image quality and presence of microscopic features
Description
The feasibility will be determined by at least one of the following parameters: 1) assessing image adequacy (resolution, contrast, etc.) qualitatively, 2) confirming that microscopic features observed in the images are also seen by correlative histopathology, 3) ability to develop preliminary criteria or algorithms based on image-histopathology matches.
Time Frame
Imaging data is collected during the procedure, and analyzed within 1 year of collection.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Scheduled for an elective esophagoduodenoscopy and/or colonoscopy
Exclusion Criteria:
• According to standard of care at MGH endoscopy department.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Tearney, M.D, PhD.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
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