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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical Device Usage and Evaluation
Best Practice
Resection
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (VR/3D-CEPs, standard treatment)

Arm II (standard treatment)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 31, 2021
Last Updated
January 4, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT05031910
Brief Title
Virtual Reality 3D-Surgery Modeling to Enhance Head and Neck Cancer Surgery Quality
Official Title
Preoperative Virtual Reality and 3D Pathologic Modeling as Treatment for Head and Neck Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2022 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (VR/3D-CEPs, standard treatment)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (standard treatment)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Medical Device Usage and Evaluation
Intervention Description
Undergo virtual reality imaging via VR/3D-CEPs
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care
Intervention Type
Procedure
Intervention Name(s)
Resection
Other Intervention Name(s)
Surgical Resection
Intervention Description
Undergo surgical resection
Primary Outcome Measure Information:
Title
Proportion of successful Virtual Reality/3 dimensional- Case Enhancement Protocols (VR3D-CEPs) to the proportion of VR3D-CEP attempts
Description
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.
Time Frame
Completion of surgical resection
Title
Quality of existing interdisciplinary intraoperative communication
Description
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.
Time Frame
Completion of surgical resection
Secondary Outcome Measure Information:
Title
Physician task load burden
Description
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.
Time Frame
Completion of surgical resection
Title
Robotic surgical difficulty
Description
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.
Time Frame
Completion of surgical resection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Curry, MD
Phone
215-955-6760
Email
Joseph.Curry@jefferson.edu

12. IPD Sharing Statement

Learn more about this trial

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

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