NCT02009085已完成不适用
Pilot Study to Asses the Identification of Melanoma in Skin Lesions.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 主要终点
- Correlation between imaging and pathology.
研究概览
简要总结
In this study a fluorescent contrast dye is applied to a suspicious skin lesion.
Images are acquired and processed. The information is used to develop a prediction model for the presence of malignant transformation in the skin.
详细描述
Images acquired in the study are used for the development of a software analysis program.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 18
- •Individual is scheduled for a skin biopsy in toto
- •The lesion is pigmented or non pigmented
- •Lesions may be under suspicion for basal cell carcinoma, squamous cell carcinoma, actinic keratosis, nevi, melanoma, seborrheic keratosis.
- •The lesion is accessible to the imaging device
排除标准
- •The patient has sensitive skin and easily breaks out in rash
- •The lesion is within 1 cm of the eye
- •The lesion is on mucosal surfaces (e.g., lips, genitals)
- •Pregnant females
- •Taking medications that pigments the skin
结局指标
主要结局
Correlation between imaging and pathology.
时间窗: No long term follow up is necessary.
Patients are imaged and then undergo a biopsy. Images are used to develop a software predicting model based on pathology. Sensitivity and specificity parameters are calculated. No long term follow up is required since the biopsy is performed on the skin imaged. The follow up required is for the pathology for the skin excised.
次要结局
- Acute response(up to 1 day)
研究者
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