Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology

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

Tracking Information

• First Submitted Date: August 11, 2020
• First Posted Date: September 25, 2020
• Last Update Posted Date: September 25, 2020
• Actual Study Start Date: March 25, 2016
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 22, 2020)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Device Feasibility

Condition

• Gastrointestinal Disease
• Gastrointestinal Dysfunction

• Intervention: Device: Biopsy imaged by Optical imaging device.

Study Arms

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.

Intervention: Device: Biopsy imaged by Optical imaging device.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: September 22, 2020): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Scheduled for an elective esophagoduodenoscopy and/or colonoscopy

Exclusion Criteria:

• According to standard of care at MGH endoscopy department.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04565704
• Other Study ID Numbers: 2015P000328
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Guillermo Tearney, Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Guillermo Tearney, M.D, PhD.; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: September 2020