Development of Artificial Intelligence Algorithms to Help Detect Potential Melanomas, Using Images From the VECTRA 3D Whole Body 360 Imaging System, a 3D Whole-body Skin Scanner.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- development and validation of algorithms to identify lesions clinically suspected of being melanoma by a dermatologist (potentially malignant and/or ugly duckling).
研究概览
简要总结
The background to this research is that frequent medical screening of the general population for melanoma is not feasible. The real challenge of this project is to develop an automatic process for detecting any potential melanoma. To this end, the project aims to design an algorithm to build a novel diagnostic aid that makes use of the similarity and disparity of pigmented lesions in the same patient. To achieve this, we need to obtain and structure a large database of images grouping all pigmented lesions per patient according to their similarities as perceived by dermatologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18 and over
- •Patient with more than 15 nevi (moles) of various phototypes (I to III)
- •Patient who has received information about the study and has not expressed any opposition
- •Patient who is a beneficiary or entitled person under a social security scheme
排除标准
- •Patients with phototype V
- •Patients with chronic inflammatory skin diseases
- •Claustrophobic patients
- •Patients who are bedridden or handicapped
- •Patients who are excluded from another research protocol at the time of collection of the non-objection.
- •Patients covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women),
- •Any other reason which, in the investigator's opinion, could interfere with the evaluation of the research objectives.
研究组 & 干预措施
Scanner of the whole body sing the VECTRA 3D
Whole body image acquisition using the VECTRA 3D Whole Body 360 Imaging System to detect potential melanoma
干预措施: Scanner of the whole body using the VECTRA 3D (Other)
结局指标
主要结局
development and validation of algorithms to identify lesions clinically suspected of being melanoma by a dermatologist (potentially malignant and/or ugly duckling).
时间窗: from enrollement to until 6 month
Comparison of the results given by the analysis of the images by 3 dermatologists or by the software. Estimation of sensitivity and specificity thresholds of at least 93% (accuracy level 5%).
次要结局
- concordance rate for malignant annotations(From enrollement to 6 month after)
- concordance rate for ugly duckling(From enrollement to 6 month after)
- calculation of the proportion of melanomas confirmed by anatomopathology(From enrollement to 6 month after)