A Study of the Use of 3D Technology to Guide Head and Neck Surgery

Not Applicable

Active, not recruiting

• Conditions: Surgery; Head and Neck Disorder

• Registration Number: NCT06676592
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-04
• Study First Posted: 2024-11-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of standard of care imaging studies successfully superimposed into 3D study framework for all participants	1 year	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.

Trial Locations

Locations (7)

Memorial Sloan Kettering at Basking Ridge (Consent Only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Consent only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Bergen (Consent only); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Westchester (Consent form); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All protocol activites); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Consent only); 🇺🇸 Rockville Centre, New York, United States