跳至主要内容
临床试验/NCT01980264
NCT01980264招募中不适用

Harmonics-based in Vivo Optical Virtual Biopsy

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2009年8月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
To noninvasively provide real-time imaging of cutaneous histopathology and molecular changes.

研究概览

简要总结

The research aims to study the molecules and structures in human skin by the image formation of harmonic-based in vivo optical virtual biopsy.

详细描述

In the research, the investigators use the Cr:forsterite laser as the light source, and utilize the nonlinear optical microscopic system to observe human skin via in vivo detection. In this study, images of human skin tissue will be acquired by virtual section to truly evaluate the feasibility of this system in clinical application.

This research intends to conduct the following research:

  1. To study the feasibility of this technology to observe melanin in the skin: As melanin is THG-bright, the technology will help to explore the distribution and change of melanin in the skin.
  2. To study the capability of this technology in the early diagnosis of skin cancers, including melanoma, basal cell carcinoma, and squamous cell carcinoma: By obtaining skin images of healthy and diseased patients, we can establish an image database of normal and cancerous skin in different atages, and evaluate the efficacy of this technology for early diagnosis of skin malignancy in the future.
  3. To study the ability of this technology to observe and analyze the degree of skin aging: Optical sectioning of human skin in a non-invasive in vivo manner can be used to detect the microscopic changes of skin aging and solar damage, and to find out the indicators of skin aging, so as to be used in the future to assist the therapeutic analysis of anti-skin aging treatment.
  4. To study the ability of this technology to observe peripheral vasculopathy and molecular changes of microvascular structures in diabetic patients: Perform microscopic imaging on healthy and diabetes patients' skin to observe effects of structures and molecules in their skin, such as peripheral vasculopathy in diabetic patients, and the status of disease parameters, with a view to find the cause of peripheral vascular lesions and other biological information.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •healthy volunteers of different skin colors and different ages
  • •patients with suspected melanoma
  • •patients with suspected basal cell carcinoma or squamous cell carcinoma
  • •patients with diabetes mellitus

排除标准

  • •volunteers have infectious disease
  • •volunteers' skin have been infected with ulceration

研究组 & 干预措施

Diagnostic imaging

Experimental

Harmonic Generation Microscopy

干预措施: Harmonic Generation Microscopy (Device)

结局指标

主要结局

To noninvasively provide real-time imaging of cutaneous histopathology and molecular changes.

时间窗: one year

To observe some analyzed molecule (melanin density, HbA1c density, collagen density, etc) \& structure (cell size, cell height, height of rete ridges, layer thickness, etc) parameters for different skin types \& age groups. (the information above can be observed in the nonlinear images) (Cell or molecule density is defined as the cell or molecule numbers in the specific image area) (Structure can be observed and reconstructed via multiple z-depth images)

次要结局

  • To provide a diagnostic tool for diseases.(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验