Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05031910

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

Location contact

Joseph Curry, MD

CONTACT

[email protected]

(215) 955-6760

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Device Usage and Evaluation

Other

Undergo virtual reality imaging via VR/3D-CEPs

Best Practice

Other

Receive standard of care

Other names: standard of care, standard therapy

Resection

Procedure

Undergo surgical resection

Other names: Surgical Resection

Primary outcomes

  1. Margin events

    Time frame: Up to Completion of surgical resection

    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.

Secondary outcomes

  1. Event free survival

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

    Logistic regression will be used to estimate an odds ratio and 95% confidence interval (CI).

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Curry, MD

CONTACT

[email protected]

215-955-6784

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2021
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.