跳至主要内容
临床试验/NCT06473103
NCT06473103招募中不适用

Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy

University of Rochester2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
2
主要终点
Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology

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 standard local excision.

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 permanent sections for final margin confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation on permanent sections, thus all patients will receive standard of care confirmation following experimental imaging. Individual excisions from consenting patients will be selected, fluorescently labeled and the distance to inked margins measured with TPFM. Following imaging, specimens will be submitted for paraffin processing as per normal procedure and the resulting slides scanned. The distance to the inked margin will be measured on the permanent sections and compared to TPFM to determine accuracy.

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

性别
All
接受健康志愿者

入选标准

  • Undergoing treatment for basal cell carcinoma without Mohs surgery at the performance site
  • Able to read and understand consent form

排除标准

  • 未提供

结局指标

主要结局

Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology

时间窗: Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery

The distance from the furthest extent of the tumor to the nearest surgical margin will be measured on both TPFM and conventional paraffin histology and the numerical difference calculated.

次要结局

  • Overall agreement on margin status(Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery)

研究者

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

Michael Giacomelli

Associate Professor

University of Rochester

研究点 (2)

Loading locations...

相似试验