Reflectance Confocal Microscopy of Wounds During Moh's Surgery: Feasibility Testing of a Mosaicing Algorithm for Intraoperative Imaging of Cancer Margins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- test feasibility of a mosaicing algorithm intraoperative
研究概览
简要总结
The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate assessment of surgical margins in the excision of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC). The investigators will evaluate the pictures obtained by the confocal microscope to determine whether this technique may be useful in the future for helping Mohs surgeons remove cancers. In the future, patients may benefit with shorter surgery and improved care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 undergoing Mohs surgery for basal cell carcinoma (BCC )or squamous cell carcinoma (SCC). .
- •Ability to sign informed consent.
- •Age ≥ 18 years.
排除标准
- •Mohs surgery located on a site that may not be convenient to confocal imaging.
- •Inability to give informed consent.
- •Inability to tolerate imaging procedure (i.e., remain relatively still for multiple short durations of 3-4 minutes) over a total time of 20 minutes.
结局指标
主要结局
test feasibility of a mosaicing algorithm intraoperative
时间窗: 1 year
For the primary study objective, the Mohs surgeon will perform a qualitative assessment of the confocal mosaic. This will be a dichotomous assessment of whether the mosaic is of sufficient quality (contrast and resolution) to identify individual features. The specific features for BCC or SCC margins are tumor nests with nuclear atypia and increased nuclear density (relative to the density seen in normal basal cells).
次要结局
- test feasibility of a mosaicing algorithm preoperative(1 year)