Early Feasibility Study: Application of OCT Imaging in Dermatology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Number of subjects with clear tissue characteristics of skin diseases and/or normal skin in tomograms
研究概览
简要总结
Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture biological images from within optical scattering media (e.g., biological tissue). A high-resolution OCT has the characteristics of non-invasive, label-free, real-time, cellular resolution with high tissue penetration depth that are highly valuable for clinical use.
AMO has developed an in-vivo OCT scanning system prototype based on the clinical needs and potential applications. This study is designed as an early feasibility study aiming for validation of AMO's in-vivo OCT scanning system in dermatology through collaboration with Mackay Memorial Hospital. The OCT can provide cellular-resolution (<1μm in lateral and axial directions) images which can be utilized to identify organelles. A high-resolution OCT has the characteristics of non-invasive, label-free, real-time, cellular resolution with high tissue penetration depth that are highly valuable for clinical use.
The proposed scenario in this study is to collecting OCT images of skins with suspicious lesion including tumor, inflammatory diseases or pigment alteration as well as normal skin by using AMO's in vivo OCT imaging system. By using traditional pathological biopsy images or dermoscopic images as gold standard references, investigators will try to identify different characteristics in OCT images of skin with suspicious lesion including tumor, inflammatory diseases, or pigment alteration as well as normal skins.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient who is fully aware of the trial and can sign the inform consent form himself/herself
- •Patients with suspected skin tumors or skin inflammations
- •Patients diagnosed for biopsy
- •Patients with no open wounds in the tumor or inflamed position
排除标准
- •Patients with a transcutaneous infectious disease
- •Patients under the age of 20
- •Vulnerable populations, including: pregnant women, handicapped, and homelessness
- •Patient cannot cooperate in examination
- •Patients with skin tumors that are in the subcutaneous tissue
结局指标
主要结局
Number of subjects with clear tissue characteristics of skin diseases and/or normal skin in tomograms
时间窗: 2 years
Number of subjects with clear tissue characteristics of tomograms will be compared to that with unclear tissue characteristics to identify the effect of the OCT on scanning skin at study completion.
Number of subjects with the distinction between skin lesion and normal skin in tomograms
时间窗: 2 years
Number of subjects with the distinction between skin lesion and normal skin in tomograms will be compared to that with no distinction to verify the specific diseases that can be distinguished from others by the OCT at study completion.
次要结局
- Number of subjects with clear tissue stratification of skin diseases and/or normal skin in tomograms(2 years)
- Number of subjects with the similarity of tissue characteristics, tissue stratification, and tissue thickness between tomograms and H&E stain(2 years)