Head and Neck Disorder, Surgery
Conditions
Keywords
head and neck surgery, Scaniverse app, Memorial Sloan Kettering Cancer Center, 24-191
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
Interventions
DIAGNOSTIC_TESTPreoperative 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_TEST3D 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
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTSnehal Patel, MD
CONTACTJoseph Stember, MD
PRINCIPAL_INVESTIGATORSnehal Patel, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed