Clinical trial NCT05031910: 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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Margin events
timeFrame: Up to Completion of surgical resection
Secondary outcomes:
measure: Event free survival
timeFrame: The time from completion of treatment to marginal recurrence of tumor at the primary site, assessed up to 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References: