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

Not Applicable

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Other: Best Practice; Other: Medical Device Usage and Evaluation; Procedure: Resection

• Registration Number: NCT05031910
• Lead Sponsor: Thomas Jefferson University

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 18-36 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 Timeline

• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-02
• Study Start: 2022-02-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09
• Primary Completion: 2026-09
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (standard treatment)	Best Practice	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.
Arm II (standard treatment)	Resection	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.
Arm I (VR/3D-CEPs, standard treatment)	Best Practice	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 I (VR/3D-CEPs, standard treatment)	Medical Device Usage and Evaluation	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 I (VR/3D-CEPs, standard treatment)	Resection	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.

Primary Outcome Measures

Name	Time	Method
Margin events	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 Outcome Measures

Name	Time	Method
Event free survival	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).

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States