Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology

Mass General Brigham

Status: Invitation-only

Conditions: Gastrointestinal Disease; Gastrointestinal Dysfunction

Treatments: Device: Biopsy imaged by Optical imaging device.

Study type: Interventional

Funder types: Other

Identifiers

NCT04565704

2015P000328

Details and patient eligibility

About

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.

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Scheduled for an elective esophagoduodenoscopy and/or colonoscopy

Exclusion criteria

• According to standard of care at MGH endoscopy department.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Development of novel optical imaging technologies

Experimental group

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.

Treatment:

Device: Biopsy imaged by Optical imaging device.