A Prospective, Non-controlled, Multicenter Clinical Study to Evaluate the Diagnostic Accuracy of the Stepwise Two Photon Excited Melanin Fluorescence of Potentially Malignant Pigmented Lesions as Compared to Histopathological Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- To determine sensitivity and specificity of the algorithm for the fluorescence diagnostics of melanoma.
研究概览
简要总结
All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histopathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients ≥ 18 years of age
- •Male or female
- •Patients having pigmented lesions with suspicion of dysplastic nevus or melanoma, in whom an excision is performed in order to exclude or diagnose malignant melanoma
- •Patients who gave their written informed consent.
排除标准
- •Patients with skin type V and VI according to Fitzpatrick's scale;
- •Where there is a risk that the scanning head is torn off be-cause the patient cannot be placed at rest (e.g. due to motoric disorders like tremor, convulsions, tics, compulsive acts
- •Patients who cannot understand the patient information and provide informed consent
- •Deep dermal lesions ≥ 5 mm beneath the stratum corneum
- •Clinically or reflected-light microscopically obviously non-melanocytic lesions
- •Peri- and subungual lesions
- •Mucosal lesions
- •Lesions with trauma, erosion (superficial defect), excoriation (defect down to the basement membrane) or ulceration (deep substantial defect) on more than 50 % of the lesion area (measurements must in any case not be carried out directly on the trauma, erosion, excoriation or ulceration)
- •Tattooed lesions
- •Pregnant or breast feeding women
- •Patients suffering from albinism
- •Lesions with dominant (>50%) regression
- •Lesions which are not suitable to fix the scanning cap
结局指标
主要结局
To determine sensitivity and specificity of the algorithm for the fluorescence diagnostics of melanoma.
时间窗: 7 days
The comparator and gold standard for the diagnosis will be the histopathological diagnosis of the pigmented lesions.
次要结局
- To collect data for training and optimization of the diagnostic algorithm.(1 day)