Two-photon Fluorescence Microscopy of Dermatologic Biopsies
Expanded Two-photon Imaging of Skin Biopsy Specimens
The goal of this study is to investigate the ability of two-photon fluorescence microscopy to evaluate dermatologic biopsies. The main questions it aims to answer are:
• How well do two-photon fluorescence images of biopsies taken in a clinic and evaluated by a pathologist agree with conventional histology?
研究概览
详细说明
This study will image biopsy specimens using two-photon fluorescence microscopy (TPFM) and then assess how well the images predict the eventual clinical diagnosis using both an expert pathologist and a machine learning model. Because two-photon images can be acquired from small biopsy specimens within minutes of excision, they could potentially be used to immediately diagnose patients, but the accuracy of TPFM for various skin conditions is unknown.
Individual biopsy specimens in a clinic lab will be imaged using TPFM. Following histological processing and patient treatment, resulting histology slides will be scanned for comparison. Images of the histology slides will be read by a pathologist to establish a gold-standard diagnosis and the official diagnosis will be recorded. TPFM images will be evaluated by a pathologist and concordance with the gold-standard determined.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Michael G Giacomelli, Ph.D
- 电话号码：5852766260
- 邮箱：mgiacome@ur.rochester.edu
学习地点
-
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New York
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Victor、New York、美国、14654
- 招聘中
- Rochester Dermatologic Surgery
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接触：
- Sherrif Ibrahim, M.D.-Ph.D.
- 电话号码：585-222-1400
- 邮箱：dr.ibrahim@rochesterdermsurgery.com
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-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Punch, excisional or shave biopsy specimen
Exclusion Criteria:
- Biopsies composed of multiple excisions or pieces
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：TPFM imaging of biopsy
Specimens will be imaged with TPFM
|
Ex vivo tissues will be imaged with two photon microscopy
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Specificity of TPFM for prediction of the official patient diagnoses
大体时间：After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
Specificity is defined as the number of true negative diagnoses divided by the sum of true negative and false positive diagnoses among biopsy specimens for which the pathologist returned a definitive diagnosis.
The patient's ultimate clinical diagnosis will serve as the reference standard.
|
After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
|
Sensitivity of TPFM for prediction of the official patient diagnoses
大体时间：After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
Sensitivity is defined as the number of true positive diagnoses divided by the sum of true positive and false negative diagnoses among biopsy specimens for which the pathologist returns a definitive diagnosis.
|
After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sensitivity of Two Photon Fluorescence Microscopy
大体时间：After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
Sensitivity of two photon fluorescence microscopy images read by a pathologist blinded to the true diagnosis will be determined.
Sensitivity is defined as the number of true positive diagnoses divided by the sum of true positive and false negative diagnoses among biopsy specimens for which there is a definitive diagnosis.
A subsequent read of the corresponding conventional histology images after a delay for washout will serve as the ground truth.
|
After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
|
Specificity of two photon fluorescence microscopy
大体时间：After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
Specificity of two photon fluorescence microscopy images read by a pathologist blinded to the true diagnosis will be determined.
Specificity is defined as the number of true negative diagnoses divided by the sum of true negative and false positive diagnoses among biopsy specimens for which there is a definitive diagnosis.
A subsequent read of the corresponding conventional histology images by the same pathologist after a delay for washout will serve as the ground truth.
|
After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- STUDY00009823A
- R37CA258376 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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