Feasibility of 3D Ultrasound in the Assessment of Resection Margins During Surgery for Squamous Cell Carcinoma of the Tongue: a Comparison With Histopathology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Correlation of the surgical margin measurements of the 3D ultrasound to histopathology
研究概览
简要总结
Complete removal of cancer encircled by a secure margin of healthy tissue is the aim of surgical oncology. A close or positive surgical margin reported by pathologist typically ends in adjuvant therapies (re-surgery and/or radiotherapy), which come with prognostic risks and financial cost. Therefore, ex-vivo imaging of removed cancer tissue may assist in margin evaluation. In this study, investigators aimed to investigate the correlation of 3D ultrasound to histopathology to assess tongue tumor margin status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 with biopsy-proven oral tongue squamous cell carcinoma scheduled for surgical treatment
- •T1-T2 staging on cross-sectional imaging
排除标准
- •Age < 18 yrs
- •T3-T4 staging
- •Unable to understand the verbal or written information
- •Prior radiotherapy treatment of oral cavity cancer
结局指标
主要结局
Correlation of the surgical margin measurements of the 3D ultrasound to histopathology
时间窗: 2 weeks
The smallest margin will be measured in mm on 3D ultrasound image of the ex-vivo surgical specimen. Correlation of the measurement to the final histopathology result will be investigated.
Diagnostic accuracy
时间窗: 2 weeks
number of margins correctly classified as free (\> 5 mm), close (\< 5 mm) or positive (\<1 mm) margin
次要结局
未报告次要终点
研究者
Fatemeh Makouei
Biomedical Engineer, PhD
Rigshospitalet, Denmark