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

NCT05031910 | Recruiting DMC

• 2 other identifiers: 21D.079JT 15475
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Event free survival

  The time from completion of treatment to marginal recurrence of tumor at the primary site, assessed up to 3 years

Study Arms (2)

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

EXPERIMENTAL

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; Other: Best Practice; Procedure: Resection

Arm II (standard treatment)

ACTIVE COMPARATOR

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; Procedure: Resection

Interventions

Medical Device Usage and Evaluation OTHER

Undergo virtual reality imaging via VR/3D-CEPs

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

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

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

Resection PROCEDURE

Undergo surgical resection

Also known as: Surgical Resection

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Central Study Contacts

Joseph Curry, MD

CONTACT

215-955-6784; joseph.curry@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 2, 2021
• Study Start: February 4, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)