Recruiting

Virtual Reality

Sponsor:

Thomas Jefferson University

Code:

NCT05031910

Conditions

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medical Device Usage and Evaluation

Best Practice

Resection

Study Details

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

Study ID

NCT05031910

Start date

Feb 4, 2022

Status verified date

Feb, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Medical Device Usage and Evaluation

Undergo virtual reality imaging via VR/3D-CEPs

Best Practice

Receive standard of care

Resection

Undergo surgical resection

Primary outcome measure

  • Margin events [ Time Frame: Up to Completion of surgical resection ]

Central Contacts and Locations

Central contacts

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

More Information

Sponsor

Thomas Jefferson University

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-02-17.