Preoperative Virtual Reality and 3D Pathologic Modeling as Treatment for Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Margin events
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Medical Device Usage and Evaluation (Other)
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.
干预措施: Best Practice (Other)
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.
干预措施: Resection (Procedure)
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.
干预措施: Best Practice (Other)
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.
干预措施: Resection (Procedure)
结局指标
主要结局
Margin events
时间窗: 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.
次要结局
- Event free survival(The time from completion of treatment to marginal recurrence of tumor at the primary site, assessed up to 3 years)