Feasibility of 3D ex Vivo Ultrasonography for Post-operative Evaluation of Tumor Margins in Cutaneous Squamous Cell Carcinoma
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Deep margin distance
概览
简要总结
This is a prospective study including patients ( ≥ 18 years) referred for surgical treatment of primary cutaneous squamous cell carcinoma at the Department of Plastic Surgery, Rigshospitalet. After written and informed consent, patients will undergo standard surgical excision, followed by ex vivo 3D ultrasonography of the specimen using a 3Sonic device connected to a high-frequency ultrasound machine. This will create 3D ultrasound tomographic scans which will be interpreted by one investigator blinded to histopathology. The investigated outcomes will primarily be the deep margin distance. This will be compared to histopathology, where a pathologist - blinded to the ultrasonography results - will slice the entire specimen parallel to the ultrasound images. A third investigator will then match the histopathology images to the ultrasound images for correlation of the measured deep margins.
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
- •Adults with primary cutaneous squamous cell carcinoma.
排除标准
- •Carcinomas located on the eyelids, vulva, penis, or perianal.
- •Tumors with an anticipated excision larger than 60mm.
研究组 & 干预措施
3D Ultrasonography
干预措施: ex vivo 3D ultrasonography (Diagnostic Test)
结局指标
主要结局
Deep margin distance
时间窗: Within 10-14 days from enrollment
The minimum deep margins in each ultrasound or histopathology tumor slide measured in millimeters from the deepest tumor border to the closest deep border of the healthy tissue (if present).
次要结局
- Depth of invasion(Within 10-14 days from enrollment)
- Tumor size in 3 dimensions measured in mm with ultrasound and histopathology(Within 10-14 days from enrollment)
研究者
Linnea Langhans
Principal investigator
Rigshospitalet, Denmark