A Study of the Use of 3D Technology to Guide Head and Neck Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Preoperative imaging, 3D framework.
- Who it may be relevant to
- Registry conditions: Surgery, Head and Neck Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Digitally Acquired 3D Framework With Superimposed Preoperative Imaging Data for Intraoperative Guidance
Overview
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
Interventions
- Diagnostic test Preoperative imaging
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. - Diagnostic test 3D framework
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
Primary outcome measures
- Proportion of standard of care imaging studies successfully superimposed into 3D study framework for all participants [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 7 centers
- Memorial Sloan Kettering at Basking Ridge (Consent Only) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Consent only) — Middletown
- Memorial Sloan Kettering Bergen (Consent only) — Montvale
- Memorial Sloan Kettering Suffolk - Commack (Consent only) — Commack
- Memorial Sloan Kettering Westchester (Consent form) — Harrison
- Memorial Sloan Kettering Cancer Center (All protocol activites) — New York
- Memorial Sloan Kettering Nassau (Consent only) — Rockville Centre
Identifiers
NCT: NCT06676592 · 24-191