Recruiting

NCT Number: NCT06676592

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

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

Recruiting

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Key information

Conditions

Surgery Head and Neck Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative imaging

Diagnostic Test

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.

3D framework

Diagnostic Test

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 outcomes

Proportion of standard of care imaging studies successfully superimposed into 3D study framework for all participants

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Stember, MD

CONTACT

[email protected]

Snehal Patel, MD

CONTACT

[email protected]

212-639-3412

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Digitally Acquired 3D Framework With Superimposed Preoperative Imaging Data for Intraoperative Guidance

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Nov 6, 2024
Registry last updated: May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed