Investigation of Mohs Surgical Margins Using Two Photon Microscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Agreement Between Frozen Sections and Two Photon Microscopy on Mohs Margins
研究概览
简要总结
The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during Mohs surgery. The main question it aims to answer is:
• How similar are diagnosis of surgical margins to on two photon fluorescence microscopy compared to frozen section histology
详细描述
This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care frozen section analysis (FSA) for confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation using cryosectioned H&E slides, thus all patients will receive standard of care confirmation following experimental imaging.
Individual excisions from consenting patients will be selected, fluorescently labeled and diagnosed using TPFM. Following imaging, specimens will be cryosectioned as per normal procedure. Following treatment, the results of the TPFM evaluation of each Mohs excisions will be compared to the results from FSA to assess the overall accuracy of TPFM and to determine if TPFM would result in changes to patient care if used without FSA confirmation.
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
- •Undergoing treatment for BCC with Mohs surgery at the performance site
- •Able to read and understand consent form
排除标准
- 未提供
研究组 & 干预措施
TPFM imaging of surgical margins
Patients will be imaged with TPFM
干预措施: Two photon microscopy imaging (Device)
结局指标
主要结局
Agreement Between Frozen Sections and Two Photon Microscopy on Mohs Margins
时间窗: During Mohs surgery
Sensitivity and specificity of TPFM on Mohs surgical margins compared to frozen sections as gold standard
次要结局
- Specificity of Frozen Sections and TPFM Accounting for Errors Caused Frozen Section Artifacts(During Mohs surgery)
- Sensitivity of Frozen Sections and TPFM on True Margin Diagnosis(During Mohs surgery)
研究者
Michael Giacomelli
Assistant Professor
University of Rochester
