A Study of the Use of 3D Technology to Guide Head and Neck Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years
Scheduled to undergo head and neck surgery in the Surgery Head and Neck Service at MSK
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Preoperative imaging
Diagnostic testPreoperative 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 test3D 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
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: Participants scheduled for head and neck surgeryExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of standard of care imaging studies successfully superimposed into 3D study framework for all participants
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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov