Virtual Reality 3D-Surgery Modeling to Enhance Head and Neck Cancer Surgery Quality

Study Overview
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Brief Summary
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This clinical trial studies the use of virtual reality technology and three dimensional surgery (3D-surgery) modeling to enhance current treatments in head and neck cancer surgery. Virtual reality 3D-surgery modeling may improve quality of surgical planning and interdisciplinary communication between surgeons and pathologists during the treatment of head and neck squamous cell cancer and ultimately increase the accuracy of planning, the quality of communication, and maximize the outcome patients with head and neck cancer experience throughout treatment.

Detailed Description
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PRIMARY OBJECTIVES: To assess the potential for preoperative virtual reality and 3D pathological modeling to reduce total number of margin events as defined in the study as the number of positive frozen margins, number of positive final margins and the number of unexpected defect driven margins. SECONDARY OBJECTIVES: To assess the impact of preoperative virtual reality and 3D pathologic modeling as treatment for head and neck squamous cell carcinoma on Event Free Survival (EFS) at 18-30 months after resection as defined by recurrence at the primary site.

Official Title
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Preoperative Virtual Reality and 3D Pathologic Modeling as Treatment for Head and Neck Squamous Cell Carcinoma

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Other: Medical Device Usage and Evaluation
* Other: Best Practice
* Procedure: Resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with head and neck squamous cell carcinoma of the mucosa Receiving treatment at Thomas Jefferson University - Center City by a fellowship-trained HNC surgeon Age > 18 Provide signed written informed consent document Exclusion Criteria: Impaired judgement or those unable to provide informed consent Anything that would place the patient at increased risk or preclude the individual's full compliance with or completion of the study Enrollment in other clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (VR/3D-CEPs, standard treatment)<br>Prior to surgery (day 0-13), patients undergo virtual reality 3D tumor resection via VR/3D-CEPs. Patients' pre-surgical CT scans are reviewed per standard of care. Patients then undergo surgical resection on day 14-29 and a 3D model of true tumor is created and imported into the virtual reality environment. | Other: Medical Device Usage and Evaluation<br>* Undergo virtual reality imaging via VR/3D-CEPs<br>Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Procedure: Resection<br>* Undergo surgical resection<br>* Other names: Surgical Resection;|
| Active Comparator: Arm II (standard treatment)<br>Prior to surgery (day 0-13), patients' pre-surgical CT scans are reviewed per standard of care. Patients then undergo surgical resection on day 14-29. | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Procedure: Resection<br>* Undergo surgical resection<br>* Other names: Surgical Resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of successful Virtual Reality/3 dimensional- Case Enhancement Protocols (VR3D-CEPs) to the proportion of VR3D-CEP attempts | Feasibility will be measured as the proportion of successful VR3D-CEPs to the proportion of VR3D-CEP attempts. Successful attempts are defined as creation 3D-True-Tumor-Model, importation into the VR environment on an Oculus Quest, and digital ink marking of surgical margins on two separate models by the head and neck cancer (HNC) surgeon and pathologist. | Completion of surgical resection | 
| Quality of existing interdisciplinary intraoperative communication | Assessed using the proposed VR/3D-CEPs as a evaluating medium. This will be achieved by measuring the X-, Y-, Z- dimension coordinate values of digital ink markings of anatomic surgical margin sampling location by HNC surgeons and consulted pathologist. | Completion of surgical resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician task load burden | Physician task load burden will be measured using the National Aeronautics and Space Administration - Task Load Index (NASA - TLX) which is a validated tool for the perceived burden of a particular task. This will be documented as an overall score as well as in individual subscale scores, which include mental demand, physical demand, temporal demand, effort, frustration, and performance. A NASA-TLX score will be administrated in reference to surgical operation for HNC surgeons and completion of consultation by pathologist. | Completion of surgical resection | 
| Robotic surgical difficulty | Will be measured as Global Evaluative Assessment for Robotic Skills (GEARS) Score. GEARS Score is a validated index used to assess robotic surgical performance across six domains (depth perception, bimanual dexterity, efficiency, force sensitivity, autonomy, and robotic control) and is completed by a supervising HNC surgeon of the enrolled-HNC surgeon. | Completion of surgical resection |