Fluorescence and Thermal Imaging of the Skin Before and During Photodynamic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Is there a correlation between body site temperature and degree of fluorescence prior to and/or during PDT
研究概览
简要总结
Photodynamic therapy (PDT) is used to treat some types of sun-damaged skin and low-grade forms of growths. A cream is applied to the skin, and the chemical in this cream is absorbed in to the skin and converted in to a 'photosensitiser'. This photosensitiser is fluorescent, meaning that it produces red light when blue light is shone on it. By measuring how much light is given off with a camera, the investigators can determine how much photosensitiser is present in the skin. Also, it is thought that more of the chemical is converted to the active photosensitiser if the skin is warmer, so the investigators plan to measure the temperature of the skin using a thermal camera. Light is shone on to the skin and this activates the photosensitiser, treating the problem area and leaving healthy skin intact. This research will increase the investigators understanding of how PDT works, and may help the investigators to improve treatment regimens so that they can be made more effective and better tolerated
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients presenting with superficial BCC or Bowen's disease (one or two lesions and diagnosed either clinically or histologically and untreated or having had no treatment for 4 months or longer)
- •Adult males and females, >18 years only
- •Capable of giving informed consent
- •Able to understand and adhere to protocol requirements
排除标准
- •Patients skin lesions have had previous treatment in the last 4 months
- •Unable to give informed consent
- •Known allergy to Metvix®
- •Known to have a light sensitive disorder
- •Pregnant, breastfeeding or planning to conceive
结局指标
主要结局
Is there a correlation between body site temperature and degree of fluorescence prior to and/or during PDT
时间窗: 12months
Body site temperature is measured before and during PDT (in degrees Celsius) as is fluorescence signal (in arbitrary fluorescence units). These are compared for each time point in the treatment for each patient.
次要结局
- Is there a correlation between temperature and/or fluorescence and treatment outcome(12months)
- phototoxicity (inflammation) measured immediately after irradiation(12months)
- How does the spatial distribution of fluorescence and temperature change prior to and during PDT(12months)
- Pain measured immediately after irradiation(12months)