Noninvasive Assessment of Muco-cutaneous Lesions In Vivo
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,010
- 试验地点
- 1
- 主要终点
- Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions
研究概览
简要总结
The purpose of this study is to find out whether using noninvasive methods to study the appearance of lesions can improve diagnostic accuracy before a biopsy is required and help guide treatment planning. The database created to store these images is called an Image Repository, and it will be used to support clinical practice, teaching and training, and future research.The High-resolution OCT (Apollo Medical Optics) device ApolloVue® S100 Image System (medical device Class II) can provide both cross-sectional and en-face images with cellular information.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a muco-cutaneous lesion(s) amenable to imaging by non-invasive tools
- •Healthy volunteer subjects
- •Ability to give informed consent or in the case of pediatric patients, assent and consent from the parent/guardian
排除标准
- •Allergy or intolerance to ultrasound gel or mineral oil used for imaging
- •Patients who are not able to comply with imaging procedure
结局指标
主要结局
Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions
时间窗: 7 years
The primary outcome of this study is to collect images from varied images devices with the dermatology service and to create an effective mechanism for the storage and dissemination of the resultant images for research purposes.
次要结局
未报告次要终点