Optical Frequency Domain Imaging for Non-melanoma Skin Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Successful imaging of lesion
研究概览
简要总结
The purpose of this research study is to find out if a non-invasive imaging device called Optical Frequency Domain Imaging (OFDI) can help doctors to see the tissue and blood vessels that are related to non-melanoma skin cancers. OFDI was designed to see microscopic details of your skin without needing to use any invasive techniques such as surgery or biopsy.
详细描述
Non-melanoma skin cancer (NMSC) is the most common cancer in the United States, with more than 750,000 diagnosed patients treated every year. Its prevalence and incidence have significantly increased over the past two decades and it has been estimated that 20% of all Americans will develop this type of cancer during their lifetime (Neville et al., 2007). Biopsy and surgical resection of NMSC can result in tissue mutilation and scaring. Therefore, there is a need for new imaging technologies that can be used to non-invasively guide biopsy and surgery.
Optical Frequency Domain Imaging (OFDI) is a second-generation imaging implementation of optical coherence tomography (OCT) developed at the Wellman Center. OFDI provides high-resolution three-dimensional imaging in tissue. It uses an interferometric depth-sectioning technique and employs a near-infrared light source. Through analysis of phase information in the recorded signal. OFDI can detect blood vessels within tissues and tumors. Importantly, OFDI-based vascular imaging can be performed without the need for exogenous contrast agents, making it relatively easy to deploy in clinical settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with Fitzpatrick skin type I-VI
- •Subjects with ages between 18 and 80 years of age
- •Presence of at least one NMSC lesion
排除标准
- •Subjects with active localized or systemic infections
- •Subjects participating in potentially confounding clinical studies of investigational therapies, either drug or device.
- •Subjects taking any topical/systemic chemotherapy or immunosuppressants
- •Subjects who are pregnant and/or breastfeeding
- •Subjects with tape adhesive allergies
结局指标
主要结局
Successful imaging of lesion
时间窗: After completion of imaging session
Images acquired of NMSC
次要结局
未报告次要终点
研究者
Benjamin Vakoc
Assistant Professor
Massachusetts General Hospital
