Evaluation of Pigmented Skin Lesions With MelaFind(R) System
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,383
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
The purpose of this clinical trial is to demonstrate that MelaFind®, a new instrument that uses machine vision for non-invasive early detection of cutaneous pigmented malignant melanoma, is safe and effective. MelaFind® acquires digital images of the lesion with illumination in different spectral bands, from visible to near infrared, and automatically analyzes these images. Diagnostic accuracy of MelaFind® and that of study dermatologists will be evaluated. The reference standard will be final interpretation of lesions by central dermatohistopathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The lesion is pigmented (i.e., melanin, keratin, blood)
- •Clinical management of the lesion by the examining dermatologist is either biopsy of the lesion in toto, or 3-month follow-up of the lesion
- •The diameter of the pigmented area is between 2 and 22 millimeters
- •The lesion is accessible to the MelaFind hand-held imaging device
- •The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form
排除标准
- •The patient has a known allergy to isopropyl alcohol
- •The lesion has been previously biopsied, excised, or traumatized
- •The skin is not intact (e.g., open sores, ulcers, bleeding)
- •The lesion is within 1 cm of the eye
- •The lesion is on mucosal surfaces (e.g., lips, genitals)
- •The lesion is on palmar hands
- •The lesion is on plantar feet
- •The lesion is on or under nails
- •The lesion is located on or in an area of visible scarring
- •The lesion contains foreign matter (e.g., tattoo, splinter, marker)
研究组 & 干预措施
Biopsied Pigmented Skin Lesions
Pigmented skin lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
干预措施: MelaFind(R) (Device)
结局指标
主要结局
Sensitivity and Specificity
时间窗: Within 120 days of Data Lock
Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.
次要结局
- Biopsy Ratio(Within 120 days of Data Lock)
- Exploratory Analyses(Within 365 days of Data Lock)