Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-31 @ 4:56 AM
Study NCT ID:
NCT04565704
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-22
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-09-22', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device Feasibility based on image quality and presence of microscopic features', 'timeFrame': 'Imaging data is collected during the procedure, and analyzed within 1 year of collection.', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['OCT', 'Optical Coherence Tomography', 'Biopsy', 'GI disease', 'Endoscopy screening', 'Endoscopic Screening'], 'conditions': ['Gastrointestinal Disease', 'Gastrointestinal Dysfunction']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Scheduled for an elective esophagoduodenoscopy and/or colonoscopy\n\nExclusion Criteria:\n\n• According to standard of care at MGH endoscopy department.'}, 'identificationModule': {'nctId': 'NCT04565704', 'briefTitle': 'Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology', 'orgStudyIdInfo': {'id': '2015P000328'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Development of novel optical imaging technologies', '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.', 'interventionNames': ['Device: Biopsy imaged by Optical imaging device.']}], 'interventions': [{'name': 'Biopsy imaged by Optical imaging device.', 'type': 'DEVICE', 'armGroupLabels': ['Development of novel optical imaging technologies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Guillermo Tearney, M.D, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator - MD, PhD, FACC, FCAP, FNAI', 'investigatorFullName': 'Guillermo Tearney', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}