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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Procedure: Resection; Other: Best Practice; Other: Medical Device Usage and Evaluation

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 18-36 months after resection as defined by recurrence at the primary site.

TERTIARY OBJECTIVE:

I. To evaluate the quality of existing interdisciplinary intraoperative communication using the proposed VR/3D-case enhancement protocols (CEPs) as an evaluating medium.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (VR/3D-CEPs + STANDARD TREATMENT): Prior to surgery (day 0-13), patients undergo virtual reality 3D tumor resection via VR/3D-CEPs. Patients' pre-surgical computed tomography (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 II (STANDARD TREATMENT): 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.

After completion of study intervention, patients are followed for up to 36 months.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Curry, MD; Phone Number: 215-955-6784; Email: joseph.curry@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Sidney Kimmel Cancer Center at Thomas Jefferson University
      • Contact: Joseph Curry, MD; Phone Number: (215) 955-6760; Email: Joseph.Curry@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with cancer of the head and neck (oral cavity, oropharynx, larynx, hypopharynx, T1-T4)
• Receiving treatment at Thomas Jefferson University - Center City by a fellowship-trained HNC surgeon
• Eligible for definitive resection
• Age > 18
• Provide signed written informed consent document

Exclusion Criteria:

• Impaired judgement or those unable to provide informed consent
• Any factor that would place the patient at increased risk or preclude the individual's full compliance with or completion of the study
• Nasopharyngeal carcinoma
• Contraindications for surgery
• Enrollment in other clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (VR/3D-CEPs, standard treatment); 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.	Procedure: Resection; Undergo surgical resection; Other Names: Surgical Resection; Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy; Other: Medical Device Usage and Evaluation; Undergo virtual reality imaging via VR/3D-CEPs
Active Comparator: Arm II (standard treatment); 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.	Procedure: Resection; Undergo surgical resection; Other Names: Surgical Resection; Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Margin events	Will be defined as the number of positive margins along with the number of unexpected defect driven margins. Will be collected for patients in the control group and patients treated with the use of preoperative planning with virtual reality (VR). Margin events will be defined as binary (yes/no) on post-operative survey to be completed by surgeons. Logistic regression will be used to evaluate of a difference in any margin event between study groups (3 dimensional [3D] VR vs. control) adjusted for surgeon.	Up to Completion of surgical resection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event free survival	Logistic regression will be used to estimate an odds ratio and 95% confidence interval (CI).	The time from completion of treatment to marginal recurrence of tumor at the primary site, assessed up to 3 years

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Standard of Care; Practice Guidelines as Topic
• Other Study ID Numbers: 21D.079; JT 15475 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No