Tumor Volume and Margin Assessment With ex Vivo 3D-ultrasound After Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Blind-assessed tumor size from fresh ex vivo US
研究概览
简要总结
Patients with biopsy-verified oropharyngeal squamous cell carcinoma or Human Papillomavirus (HPV)-positive unknown primary treated with transoral robotic surgery are included. Immediately post-operatively, freshly resected specimens are examined with ex vivo 3D ultrasound (US).
Ex vivo 3D US will be used to match US slices of the specimen with corresponding histopathology slices. The US slices will be reviewed by a panel of head and neck surgeons blinded to histopathology.
The primary aim is to explore perioperative ex vivo 3D US for oropharyngeal tumor detection, delineation from normal tissue, tumor size and volume, and margin assessment.
详细描述
The purpose of the study is to determine the accuracy of ex vivo 3D ultrasound (US) for detecting and delineating tumor tissue of the tonsils and base of tongue post-operatively. This is a quick technique that may provide valuable information for the surgeon that can potentially improve treatment outcomes.
Placing the surgical specimen in a water bath allows for an US swipe to be performed without compressing the specimen. This reduces the deformation of the specimen by removing the pressure from conventional US scanning. A video clip can be captured by swiping across the specimen in the water bath. By motorizing this motion, the video can be converted into a 3D volume due to the known number of video frames and a constant swiping speed.
We will correlate the ex vivo 3D US scans to histopathology for the following analyses:
- Four surgeons blinded to histopathology will rate each included case in terms of tumor visibility on ex vivo 3D US scans. If visible, the surgeons will mark the tumor and the healthy tissue.
- Tumor and margins will be correlated to histopathology pre- and post-formalin fixation on a subset of cases to explore the proportion of tissue shrinkage from formalin fixation.
- Two methods of estimating tumor volume will be compared: the ellipsoidal formula and full 3D segmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients surgically treated with transoral robotic surgery for oropharyngeal squamous cell carcinoma or HPV-positive unknown primary.
排除标准
- •No primary tumor found on final histopathology.
研究组 & 干预措施
Post-operative ex vivo 3D ultrasound
3D ultrasound of surgical specimen
干预措施: Ultrasound (Diagnostic Test)
结局指标
主要结局
Blind-assessed tumor size from fresh ex vivo US
时间窗: day 1
Tumor width and thickness (mm) estimated by blinded perioperative ex vivo 3D-US
Blind-assessed deep and lateral margin measurements on fresh ex vivo US
时间窗: day 1
Deep and lateral margin measurements (mm) by blinded perioperative ex vivo 3D-US.
次要结局
- Margin involvement (categorical)(day 1)
- Fresh vs formalin-fixed ex vivo US tumor volume(day 1)
研究者
Martin Garset-Zamani, MD
Principal Investigator
Rigshospitalet, Denmark
