In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Sensitivity
研究概览
简要总结
OCTAV is a medical device class I, not CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).
详细描述
At the coming of the patient in Dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the OCTAV device (about 5 minutes) for the study. Then, according to usual practice, resection / biopsy will be performed.
This study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision
- •Consent form signed
- •Major patient
排除标准
- •Allergy or intolerance to immersion oil (used for microscopy)
- •If female, pregnant or breast-feeding
- •Patient unable to stand still for 60 seconds
- •Skin lesions located near patient eyes (<3 cm)
- •FOR CONTROL GROUP
- •Inclusion Criteria:
- •Aged between 18 to 40 years
- •Consent form signed
- •Patient of the dermatology department with non-pathological forearm skin
- •Exclusion Criteria:
- •Allergy or intolerance to immersion oil (used for microscopy)
- •If female, pregnant or breast-feeding
- •Patient unable to stand still for 60 seconds
研究组 & 干预措施
OCTAV Control group
Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)
干预措施: OCTAV Control group (Device)
OCTAV Patient
The patients who will have a biopsy of skin suspected to be a melanoma, basal cell carcinoma or squamous cell carcinoma will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)
干预措施: OCTAV Patient (Device)
结局指标
主要结局
Sensitivity
时间窗: Day 1
Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)
Specificity
时间窗: Day 1
Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)
次要结局
- Measure of the thickness of the different skin layers (mm)(Day 1)