Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- composite endpoint
研究概览
简要总结
The diagnosis of cutaneous lesions often involves the use of surgical and invasive procedures such as biopsy or excision in order to analyze the structure and appearance of the fabric pathologists. With recent advances in optical and electronic fields, considerable efforts were produced to build high-performance optical instruments, able to transcribe the internal structure of the skin with varying degrees of depth and variable resolution.
The imagery is now an area of great interest for medical diagnosis: non-invasive, quick, and in real time. This area is booming and new optical instruments are created to eventually be able to offer a reliable alternative to invasive techniques.
The optical properties of different tissues have been studied for several years by different research groups: the coefficient of light absorption by the tissue both in vivo and in vitro, the coefficient of light scattering or the index refractive were characterized in various tissues that make up the skin.
Other studies have focused on melanoma detection by multispectral optical techniques, or via the technique of optical coherence tomography (OCT) performed on lesions suspicious for cancer, but without linking criteria between these two techniques.
However, no study to date and to our knowledge has been able to demonstrate the different optical parameters obtained with OCT and can be directly connected to known and histopathological parameters commonly used in the diagnosis of lesions skin. This study aims to verify if it is possible to determine the parameters measured in OCT that would discriminate between benign and malignant lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with suspicious skin lesions of malignant tumor (mostly non-melanoma: basal cell carcinoma, epidermoid carcinoma and actinic keratoses, or melanoma: melanoma, nevi) requiring biopsy / surgical excision;
- •consent signed
排除标准
- •Any dermatosis, hyperalgesic lesion, and / or infected and / or topography making it impossible measurements;
- •pregnant and nursing women
- •patients under tutorship or curatorship
研究组 & 干预措施
Optical Coherence Tomography (OCT)
干预措施: Optical Coherence Tomography (OCT) with Skintell (Device)
Optical Coherence Tomography (OCT)
干预措施: Optical Coherence Tomography (OCT) with Vivosight (Device)
结局指标
主要结局
composite endpoint
时间窗: at baseline
thickness of the epidermis (µm), thickness of the dermis (µm), limit of epidermis/dermis, homogeneity of the epidermis, homogeneity and structure of the papillary dermis, vascular network associated, homogeneity of the reticular dermis, wall of vacuoles and nodules (presence or absence)
次要结局
- the duration of analysis image(at baseline)
- implementation duration(at baseline)
- acquisition practices duration(at baseline)
- utility of labeling with a dye for histology to locate the lesion(at baseline)