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临床试验/NCT03619356
NCT03619356Enrolling By Invitation不适用

Investigation of Hemoglobin Oxygenation With Third Harmonic Generation Microscopy

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
1
主要终点
Observe the extent of tumor growth via spectral THG intensity distribution

研究概览

简要总结

The specific aims of the project are performing a pre-clinical study on a human model and evaluating the oxygenation and other status of human erythrocytes by spectrally-resolved third harmonic generation (srTHG) microscopy . By analyzing the partitioned third harmonic generation (THG) spectra of oxygenated and deoxygenated erythrocytes ex vivo, the investigators aim to provide a reference standard for quantifying oxygenation and molecular status in this project.

详细描述

Recently, oximeter, detecting the spectral response at wavelengths of 660nm and 940nm, is widely used to measured oxygenation status. Its low spatial resolution and limited penetration depth in human skin, however, restrict the oximeter in clinical application especially for early detection of cancer. In early-stage cancer development, angiogenesis and oxygen depletion around tumor are two important indicators of tumor growth. If an angiogenesis and low oxygenation status can be identified simultaneously, the investigators can point out the early-stage tumor from normal tissue easily.

The investigators have been working towards the development of third harmonic generation microscopy systems and reported the success of revealing morphology in human skin specimen. Since THG process is based on virtual transition without energy deposition, THG microscopy enables imaging ex vivo specimens without extra label and invasive procedure. To further investigate biological process of biomaterials, the investigators develop a srTHGM where THG spectrum is partitioned to analyze during imaging process. In this project, the investigators aim to elucidate oxygenation concentration and other specific biological molecular of red blood cells through the srTHG microscopy system.

The abilities to reveal structure morphology and its corresponding biological information in situ would provide assistance to diagnose early-stage of tumor and other diseases as well as a potential support in clinical treatment.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •older than 20 years old

排除标准

  • •Vulnerable groups, such as pregnant women, prisoners, students, mentally handicapped, aborigines, etc.

结局指标

主要结局

Observe the extent of tumor growth via spectral THG intensity distribution

时间窗: 2 years

To observe the extent of tumor growth (with units of mm2) via spectral THG distributions. The spectral distributions are presented by the ratio between different channels. And the ratio can be calculated by analyzing the excited fluorescence intensity.

Observe the extent of tumor growth via morphological information

时间窗: 2 years

To observe the extent of tumor growth (with units of mm2) via morphological information. Morphological information are presented as density and shape of red blood cells.

Change in spectral THG strength distribution

时间窗: 2 years

Obtain THG strength in 3 different channels for chemically treated whole blood samples for oxygenation, deoxygenation and other status. The spectral distributions are presented by the ratio between different channels.

次要结局

  • Quantify the extent of diseases in spectral THG strength distribution(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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