NCT02193581已完成不适用
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The MDS produces a score between 1 to 10.
研究概览
简要总结
The use of MDS to access the presence of melanoma in the skin.
详细描述
A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy.
- •The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
- •Male and female ≥ 21 years old.
- •Subject is capable of giving written informed consent.
- •Primary excision.
排除标准
- •The lesion is less than 1 cm from the eyes.
- •The lesion is on the palms of hands or soles of the feet.
- •Mucosal lesion.
- •Pregnant females.
- •Low study procedure compliance.
- •Patients who are mentally or physically unable to comply with all aspects of the study.
- •Undergoing chemotherapy.
- •Minor or legally incompetent and not able to sign the consent form.
- •Patient previously tested by MDS and was diagnosed with melanoma during the study.
- •Sensitivity to fluorescein
结局指标
主要结局
The MDS produces a score between 1 to 10.
时间窗: 28 days
The score is a composite of the images of the mole, plus demographic and clinical information. The score is ranked from 1 to 10, with 1 being the lowest risk for melanoma, and 10 being the highest risk.
次要结局
未报告次要终点
研究者
研究点 (1)
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