NCT02056522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
- 357
- 试验地点
- 2
- 主要终点
- To validate the performance of MDS
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 97 Years（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.
结局指标
主要结局
To validate the performance of MDS
时间窗: 28 days
次要结局
- To calculate and specify the PPV and NPV of the MDS for melanoma detection when used as an adjacent tool to visual skin examination.(28 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical ImagingSkin LesionNCT02193581Orlucent, Inc50
已完成
1 期
ovel diagnostic method for malignant melanoma using fluorescence in situ hybridization (FISH) methodmalignant melanomaJPRN-UMIN000026396Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University5
已完成
不适用
Pilot Study to Determine Feasibility of Benign and Malignant Skin Lesion Detection.Skin LesionsNCT02009085Orlucent, Inc126
已完成
不适用
Investigating the Clinical Utility of the MDSSkin LesionMolesMelanomaNCT03109327Orlucent, Inc250
终止
不适用
Use of Fiber-optic Probe for Non-invasive Diagnosis of Melanoma and Assessment of Impact of Ultraviolet (UV) Exposure on SkinMelanomaNCT01085396University of Pittsburgh16