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临床试验/NCT01662713
NCT01662713已完成不适用

Optical Frequency Domain Imaging for Non-melanoma Skin Cancers

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年3月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin Vakoc

Assistant Professor

Massachusetts General Hospital

研究点 (2)

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