Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-20 @ 6:02 AM
Study NCT ID:
NCT06676592
Status:
RECRUITING
Last Update Posted:
2025-10-09
First Post:
2024-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Use of 3D Technology to Guide Head and Neck Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2024-11-01', 'studyFirstSubmitQcDate': '2024-11-04', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of standard of care imaging studies successfully superimposed into 3D study framework for all participants', 'timeFrame': '1 year', 'description': 'The primary objective of this study is to develop the technology of a 3D framework profile with superimposed preoperative imaging for intraoperative use. The process of developing the imaging technique will be considered successful if the imaging techniques and the hardware used are able to superimpose information from standard of care imaging studies into the 3D study framework for each participant.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['head and neck surgery', 'Scaniverse app', 'Memorial Sloan Kettering Cancer Center', '24-191'], 'conditions': ['Surgery', 'Head and Neck Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to test how the new 3D technology can be used to help improve the surgeon's ability to use information from standard imaging scans to guide head and neck surgery. Researchers will use the Scaniverse app during a standard ultrasound to create 3D images of participants' head and neck before their standard surgery. Researchers will see if the creation of a 3D framework profile with superimposed standard imaging scan information can be useful to the surgeon for guiding head and neck surgery"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18 years\n* Scheduled to undergo head and neck surgery in the Surgery Head and Neck Service at MSK\n\n o Note: If, for some reason, the participant is not scheduled to have standard preoperative imaging procedures, then the participant will have an ultrasound of the head and neck for research purposes.\n* Scheduled to undergo standard of care preoperative imaging (ie, ultrasound (US), computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)) in the Radiology Service at MSK\n* Ability to understand and sign (or their legally acceptable representative (LAR) must sign) the written informed consent\n\nExclusion Criteria:\n\n* Previous head and neck surgery or head and neck radiation\n* Any condition which, in the judgement of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study'}, 'identificationModule': {'nctId': 'NCT06676592', 'briefTitle': 'A Study of the Use of 3D Technology to Guide Head and Neck Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Digitally Acquired 3D Framework With Superimposed Preoperative Imaging Data for Intraoperative Guidance', 'orgStudyIdInfo': {'id': '24-191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants scheduled for head and neck surgery', 'description': 'Participants are scheduled to undergo head and neck surgery in the Surgery Head and Neck Service at MSK', 'interventionNames': ['Diagnostic Test: Preoperative imaging', 'Diagnostic Test: 3D framework']}], 'interventions': [{'name': 'Preoperative imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Preoperative imaging will be performed as part of the standard of care. Imaging data from US, CT, MRI, and/or PET performed for routine care will be used for this study.', 'armGroupLabels': ['Participants scheduled for head and neck surgery']}, {'name': '3D framework', 'type': 'DIAGNOSTIC_TEST', 'description': "3D images of surface landmarks will be acquired by use of US and the Scaniverse app before surgery, in conjunction with the participant's standard-of-care US or US-guided biopsy procedure", 'armGroupLabels': ['Participants scheduled for head and neck surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Snehal Patel, MD', 'role': 'CONTACT', 'phone': '212-639-3412'}], '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': 'Snehal Patel, MD', 'role': 'CONTACT', 'phone': '212-639-3412'}], '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': 'Snehal Patel, MD', 'role': 'CONTACT', 'phone': '212-639-3412'}], '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': 'Snehal Patel, MD', 'role': 'CONTACT', 'phone': '212-639-3412'}], 'facility': 'Memorial Sloan Kettering 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': 'Snehal Patel, MD', 'role': 'CONTACT', 'phone': '212-639-3412'}], 'facility': 'Memorial Sloan Kettering Westchester (Consent form)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Snehal Patel, MD', 'role': 'CONTACT', 'phone': '212-639-3412'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All protocol activites)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Rockville Centre', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Snehal Patel, MD', 'role': 'CONTACT', 'phone': '212-639-3412'}], 'facility': 'Memorial Sloan Kettering Nassau (Consent only)', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'centralContacts': [{'name': 'Snehal Patel, MD', 'role': 'CONTACT', 'email': 'patels@mskcc.org', 'phone': '212-639-3412'}, {'name': 'Joseph Stember, MD', 'role': 'CONTACT', 'email': 'StemberJ@mskcc.org'}], 'overallOfficials': [{'name': 'Snehal Patel, 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 beginning 12 months after publication and for up to 36 months post publication. 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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}