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Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology

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. Identifier: NCT04565704
Recruitment Status : Enrolling by invitation
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Disease Gastrointestinal Dysfunction Device: Biopsy imaged by Optical imaging device. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
Actual Study Start Date : March 25, 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Development of novel optical imaging technologies
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.
Device: Biopsy imaged by Optical imaging device.

Primary Outcome Measures :
  1. Device Feasibility based on image quality and presence of microscopic features [ Time Frame: Imaging data is collected during the procedure, and analyzed within 1 year of collection. ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

• Scheduled for an elective esophagoduodenoscopy and/or colonoscopy

Exclusion Criteria:

• According to standard of care at MGH endoscopy department.

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 identifier (NCT number): NCT04565704

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Guillermo Tearney, M.D, PhD. Massachusetts General Hospital
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Responsible Party: Guillermo Tearney, Principal Investigator - MD, PhD, FACC, FCAP, FNAI, Massachusetts General Hospital Identifier: NCT04565704    
Other Study ID Numbers: 2015P000328
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
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: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
Optical Coherence Tomography
GI disease
Endoscopy screening
Endoscopic Screening
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases