Pilot Study of Raman Spectroscopic Imaging for Skin Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin.
研究概览
简要总结
The goal of this observational study is to find out if Raman Spectroscopy, a type of imaging, can be used to determine the size of skin cancer tumors. The main question it aims to answer is:
-Can Raman Spectroscopy help figure out how far a tumor spreads?
This study will take measurements using laser light from an experimental, handheld probe by lightly touching the skin.
详细描述
Radiation therapy is an alternative to surgery for localized tumors with excellent tumor control and cosmetic outcome. Raman Spectroscopy has potential to be a useful non-invasive, non-destructive, real-time, in-vivo tool for differentiation of cancerous vs. non-cancerous tissues. With this knowledge and future studies, this will ultimately guide skin brachytherapy more accurately and avoid unnecessary radiation to cosmetically and functionally important tissues including eyelid, nose, lips or skin folds.
The purpose of this study is to determine the feasibility of Raman Spectroscopy to identify microscopic infiltration extent of skin cancer beyond grossly visible tumor, using artificial intelligence methods of supervised and un-supervised machine learning algorithms, including pattern recognition, convolutional neural networks, k-means clustering and principal component analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed skin cancer (either basal cell carcinoma or squamous cell carcinoma)
- •Participants must plan to receive brachytherapy treatment for the skin cancer at the study site.
- •Ability to provide consent to the study.
排除标准
- •Patient belongs to a vulnerable population (Minors (under 18 years old), Adults unable to consent, prisoners).
- •Lesions on the eyelid or in close proximity to the eye
- •Pregnant women, or women of childbearing age who refuse pregnancy testing.
- •Patient has pacemaker.
结局指标
主要结局
Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin.
时间窗: 1 year
Collect the Raman spectroscopy data starting from the center of visible lesion moving outward and also contralateral normal skin. Observe the different spectra peak wavelengths and intensities, which correspond to different chemical composition of the tissue. The Raman Spectra has units of wavelength Raman shift (1/centimeter) on the horizontal axis and arbitrary units of intensity on the vertical axis.
次要结局
- Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin(1 year)
- Compare the size of clinically defined margin and Raman-defined margin(1 year)
研究者
Tiezhi Zhang
Medical Physicist, Clinical Assistant Professor
Stony Brook University