3D imaging with Scaniverse to guide head and neck surgery
Digitally Acquired 3D Framework With Superimposed Preoperative Imaging Data for Intraoperative Guidance
This study will test whether creating 3D images from standard scans and an ultrasound using the Scaniverse app helps surgeons plan and guide head and neck surgery for adults at MSK.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06676592 on ClinicalTrials.gov |
What this trial studies
Researchers will use the Scaniverse app during a standard preoperative ultrasound to create 3D reconstructions of the head and neck and will superimpose those reconstructions on routine imaging (CT, MRI, PET, or ultrasound) to form a combined 3D framework. Adult participants scheduled for head and neck surgery at MSK will undergo the imaging as part of their usual preoperative workup or an added research ultrasound if no standard imaging is available. Surgeons will use the 3D framework to guide anatomical orientation and surgical planning and the study will document how useful the framework is in the operative setting. The trial focuses on feasibility and clinical utility of the 3D workflow rather than testing a therapeutic device or drug.
Who should consider this trial
Good fit: Adults aged 18 or older who are scheduled for head and neck surgery within the MSK Head and Neck Service and who will have standard preoperative imaging are ideal candidates.
Not a fit: Patients with prior head and neck surgery or prior head and neck radiation are excluded and therefore would not receive benefit from this study.
Why it matters
Potential benefit: If successful, the technique could give surgeons a clearer, patient-specific 3D view of anatomy that may improve planning and accuracy of head and neck operations.
How similar studies have performed: Some prior work using 3D reconstructions and patient-specific models has shown promise for surgical planning, but using a consumer 3D app like Scaniverse with ultrasound for head and neck guidance is relatively novel with limited published evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering at Basking Ridge (Consent Only) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Consent only) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Consent only) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk - Commack (Consent only) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Consent form) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All protocol activites) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Consent only) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Snehal Patel, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Snehal Patel, MD
- Email: patels@mskcc.org
- Phone: 212-639-3412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.