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Machine Learning Analysis of Two-photon Fluorescence Microscopy of Dermatologic Biopsies

2026年8月15日 更新者:Michael Giacomelli、University of Rochester

Machine Learning Analysis of Expanded Two-photon Imaging of Skin Biopsy Specimens

The goal of this study is to investigate the ability of a machine learning model to evaluate two-photon fluorescence microscopy images of dermatologic biopsies at point of care.

The main question it aims to answer is:

• How well do two-photon fluorescence images of biopsies taken in a clinic and evaluated by a machine learning model agree with conventional histology?

研究概览

详细说明

This study will image biopsy specimens at point of care using two-photon fluorescence microscopy (TPFM) and then assess how well the images predict the eventual clinical diagnosis using 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 dermatology clinic will be imaged using TPFM shortly after biopsy procedures. Immediately following imaging, a machine learning model will evaluate the TPFM images then compute a confidence score for a diagnosis of basal cell carcinoma (BCC), squamous cell carcinoma, and non-cancer. The relative confidence in each diagnosis will be compared, and if sufficient confidence is achieved, the model will render a diagnosis or else flag the specimen as indeterminate for manual pathologist review. This workflow will evaluate the use of ML + TPFM to perform point of care diagnosis of skin lesions.

Following TPFM imaging, the specimen will be submitted for histological processing, which will guide actual patient treatment. Following conclusion of patient treatment, the resulting histology slides will be scanned for comparison and the final patient diagnosis recorded. Images of the histology slides will be read by a pathologist to establish a gold-standard diagnosis. The official diagnosis and the diagnosis from the collaborating pathologist will be compared.

Patient treatment will still be decided by conventional histopathology. TPFM will not be used to change treatment.

研究类型

介入性

注册 (估计的)

92

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

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

不

描述

Inclusion Criteria:

  • Punch, excisional or shave biopsy specimen

Exclusion Criteria:

  • Biopsy indication includes melanoma or dysplastic/atypical nevus
  • Excision thickness of less than 1 mm
  • Excision longest dimension less than 2 mm
  • Excision performed as multiple pieces in a single specimen container

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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 and diagnosed using a machine learning model
Ex vivo tissues will be imaged with two-photon microscopy and analyzed with machine learning for diagnosis

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
Sensitivity of Machine Learning Analysis of Two Photon Fluorescence Microscopy Images At Point of Care
大体时间:During or immediately following patient biopsy (same day)
A machine learning model will evaluate TPFM images of patient biopsies at point of care. Sensitivity will be calculated for the machine learning model using two photon fluorescence microscopy images. 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 machine learning model provides a definitive diagnosis. The patient's ultimate clinical diagnosis will serve as the reference standard.
During or immediately following patient biopsy (same day)
Specificity of Machine Learning Analysis of Two Photon Fluorescence Microscopy Images At Point of Care
大体时间:During or immediately following patient biopsy (same day)
A machine learning model will evaluate TPFM images of patient biopsies at point of care. Specificity will be calculated for the machine learning model using two photon fluorescence microscopy images. 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 machine learning model provides a definitive diagnosis. The patient's ultimate clinical diagnosis will serve as the reference standard.
During or immediately following patient biopsy (same day)

次要结果测量

结果测量
措施说明
大体时间
Proportion of Discordant Diagnoses Attributable to Machine Learning Model Interpretation Errors
大体时间:After completion of patient diagnosis (typically 1-2 weeks after procedure)
For biopsy specimens with discordant diagnoses between the machine learning model and the patient's ultimate clinical diagnosis, a dermatopathologist will review each case and classify the source of disagreement as machine learning model interpretation error, image quality limitation, or image coregistration error. The proportion of discordant diagnoses attributable to each source of disagreement will be reported.
After completion of patient diagnosis (typically 1-2 weeks after procedure)
Proportion of Biopsy Specimens With a Definitive Machine Learning Diagnosis
大体时间:During or immediately following patient biopsy (same day)
The proportion of biopsy specimens for which the machine learning model provides a definitive diagnosis based on two photon fluorescence microscopy images will be calculated as the number of specimens receiving a definitive diagnosis divided by the total number of specimens evaluated.
During or immediately following patient biopsy (same day)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月24日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年6月25日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月15日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • STUDY00009823B
  • 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)?

是的

IPD 计划说明

Deidentified sets of two-photon images and corresponding conventional histology will be made available upon request. Links to full resolution image data will be included in publications along with the results of machine learning analysis.

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

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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