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临床试验/NCT05814900
NCT05814900已完成不适用

Investigation of Mohs Surgical Margins Using Two Photon Microscopy

University of Rochester1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2023年6月20日最近更新:
适应症
干预措施

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Giacomelli

Assistant Professor

University of Rochester

研究点 (1)

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