A Study of the Use of 3D Technology to Guide Head and Neck Surgery
Digitally Acquired 3D Framework With Superimposed Preoperative Imaging Data for Intraoperative Guidance
1 other identifier
interventional
27
1 country
7
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable surgery
Started Nov 2024
Typical duration for not_applicable surgery
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedFirst Posted
Study publicly available on registry
November 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
May 6, 2026
April 1, 2026
3 years
November 1, 2024
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of standard of care imaging studies successfully superimposed into 3D study framework for all participants
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.
1 year
Study Arms (1)
Participants scheduled for head and neck surgery
EXPERIMENTALParticipants are scheduled to undergo head and neck surgery in the Surgery Head and Neck Service at MSK
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Aged ≥18 years
- Scheduled to undergo head and neck surgery in the Surgery Head and Neck Service at MSK
- 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.
- 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
- Ability to understand and sign (or their legally acceptable representative (LAR) must sign) the written informed consent
You may not qualify if:
- Previous head and neck surgery or head and neck radiation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (Consent only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent form)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent only)
Rockville Centre, New York, 11553, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Snehal Patel, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2024
First Posted
November 6, 2024
Study Start
November 1, 2024
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.