Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
NCT ID: NCT04565704
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
200 participants
INTERVENTIONAL
2016-03-25
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optical Coherence Tomography of the Gastrointestinal Tract
NCT00579748
I-scan With Magnification for the Detection of Gastric Intestinal Metaplasia
NCT02516735
Artificial Intelligence-assisted Confocal Laser Endomicroscopy Identification of Intestinal Metaplasia Severity
NCT05462743
Diagnosis of Gastric Intestinal Metaplasia With High Definition Endoscopy and Optic Enhancement
NCT02725034
Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma
NCT01642797
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Biopsy imaged by Optical imaging device.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biopsy imaged by Optical imaging device.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Massachusetts General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Guillermo Tearney
Principal Investigator - MD, PhD, FACC, FCAP, FNAI
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guillermo Tearney, M.D, PhD.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015P000328
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.