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

Official title

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

Overview

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.

Interventions

• Other Medical Device Usage and Evaluation
  Undergo virtual reality imaging via VR/3D-CEPs
• Other Best Practice
  Receive standard of care
• Procedure Resection
  Undergo surgical resection

Primary outcome measures

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

Secondary outcome measures (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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia

Identifiers

NCT: NCT05031910 · 21D.079 · JT 15475

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗