Assessing Tissue Remodeling in the Skin Using Skin Fluorescence Imaging (SFI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 6
- 主要终点
- Correlation
研究概览
简要总结
The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin
详细描述
The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin. SFI analyzes the topical staining of the skin surface using the ORL-1 dye to reveal the presence of remodeling in the skin, together with the visible feature characteristics. The system provides a biometric score corresponding to the dye staining, a structural score, and a composite SFI score to quantify the presence of tissue remodeling and the process of melanocytic transition in the skin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a pigmented skin lesion recommended for a skin biopsy.
- •A lesion that is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
- •At least 21 years old.
- •Written, signed, and dated informed consent
- •Scheduled for a primary excision/biopsy as part of the clinics SOC.
排除标准
- •Lesion is less than 1 centimeter from the eyes.
- •Lesion is on the palms of the hands or soles of the feet.
- •Mucosal lesion.
- •Ulcerated lesion.
- •Subject is pregnant or planning to become pregnant during the study period.
- •Patients who are mentally or physically unable to comply with all aspects of the study.
- •Any subject undergoing chemotherapy.
- •Any lesion that has been treated with local anesthesia such as lidocaine prior to enrollment that would confound study results.
结局指标
主要结局
Correlation
时间窗: 1 day
To identify histological features that correlate with the imaging features captured using SFI
次要结局
未报告次要终点