Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:12 AM
Study NCT ID:
NCT07449195
Status:
RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005134', 'term': 'Eye Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-02-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality for participants', 'timeFrame': 'Up to 1 year', 'description': 'Evaluated by next-generation swept-source OCT versus standard OCT for imaging of the eye and any relevant ocular tumors.'}, {'measure': 'Field of view for participants', 'timeFrame': 'Up to 1 year', 'description': 'Evaluated by next-generation swept-source OCT versus standard OCT for imaging of the eye and any relevant ocular tumors.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ocular Tumors', '25-314', 'Memorial Sloan Kettering Cancer Center'], 'conditions': ['Ocular Tumor']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two devices used for optical coherence tomography (OCT). OCT is a noninvasive imaging (scanning) method that uses reflected light to create pictures of the back of the eye, and doctors can use OCT to detect and monitor different types of cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* At least 1 eye that has an intraocular or ocular surface tumor.\n* The presence of a natural crystalline lens or intraocular lens.\n* Pupils that can dilate up to at least 3 mm in the study eyes.\n* The absence of opaque natural crystalline lenses or the presence of any ocular disease that prevents the view of the retina for imaging.\n* Patients must be able to fixate on the imaging target.\n* Patients must be able to sit still for a period of time (approximately 2 minutes).\n\nExclusion Criteria:\n\n* Does not meet ALL of the above conditions'}, 'identificationModule': {'nctId': 'NCT07449195', 'briefTitle': 'A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Ocular Imaging for Monitoring of Ocular Tumor Disease', 'orgStudyIdInfo': {'id': '25-314'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with Ocular Tumor', 'description': 'Participants will have at least 1 eye that has an intraocular or ocular surface tumor.', 'interventionNames': ['Diagnostic Test: Intalight Dream OCT', 'Diagnostic Test: Heidelberg Spectralis OCT']}], 'interventions': [{'name': 'Intalight Dream OCT', 'type': 'DIAGNOSTIC_TEST', 'description': 'This is a next-generation swept-source device that has a faster imaging speed and higher sensitivity than the previous generation of frequency-domain OCT devices, which serve as the current standard of care devices.', 'armGroupLabels': ['Participants with Ocular Tumor']}, {'name': 'Heidelberg Spectralis OCT', 'type': 'DIAGNOSTIC_TEST', 'description': 'This is the standard of care for optical imaging.', 'armGroupLabels': ['Participants with Ocular Tumor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jasmine Francis, MD', 'role': 'CONTACT', 'phone': '212-639-7266'}], 'facility': 'Memorial Sloan Kettering at Basking Ridge (Consent Only)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jasmine Francis, MD', 'role': 'CONTACT', 'phone': '212-639-7266'}], 'facility': 'Memorial Sloan Kettering Monmouth (Consent only)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jasmine Francis, MD', 'role': 'CONTACT', 'phone': '212-639-7266'}], 'facility': 'Memorial Sloan Kettering Bergen (Consent Only)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jasmine Francis, MD', 'role': 'CONTACT', 'phone': '212-639-7266'}], 'facility': 'Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jasmine Francis, MD', 'role': 'CONTACT', 'phone': '212-639-7266'}], 'facility': 'Memorial Sloan Kettering Westchester (Consent Only)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jasmine Francis, MD', 'role': 'CONTACT', 'phone': '212-639-7266'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activites)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jasmine Francis, MD', 'role': 'CONTACT', 'phone': '212-639-7266'}], 'facility': 'Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'centralContacts': [{'name': 'Jasmine Francis, MD', 'role': 'CONTACT', 'email': 'francij1@mskcc.org', 'phone': '212-639-7266'}, {'name': 'David Abramson, MD', 'role': 'CONTACT', 'email': 'abramsod@mskcc.org', 'phone': '212-639-7232'}], 'overallOfficials': [{'name': 'Jasmine Francis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Intalight, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}