Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
Gastrointestinal Disease · Gastrointestinal Dysfunction
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 200 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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 participants 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 participants 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
• Scheduled for an elective esophagoduodenoscopy and/or colonoscopy
Exclusion Criteria:
• According to standard of care at MGH endoscopy department.
Understand screeningTreatment, groups and participation
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- Assignment
- Not applicable
- Masking
- No masking
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.
Biopsy imaged by Optical imaging device. DEVICE
Not reported in this registry record.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
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1 locations
Massachusetts General HospitalBoston, Massachusetts, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- Massachusetts General Hospital
- Study start
- Mar 25, 2016 Actual
- Primary completion
- Dec 31, 2028 Estimated
- Study completion
- Dec 31, 2029 Estimated
- First posted
- Sep 25, 2020 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026