Medical Device Based on Polarized Light for Cutaneous Lesions Visualization

Study Overview
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Brief Summary
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Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions thus is a priority. The diagnosis gold standard is based on the combination of clinical and histopathological examinations. Nevertheless, the clinical examination is not sufficiently effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help dermatologists in diagnosing skin lesions. This medical device combined with its software is a strong and ergonomic spectro-polarimetric imager instrument. It can realize images of the superficial cutaneous tissues and subcutaneous tissues close to the surface by exploiting polarized light properties. This first clinical trial aims to demonstrate that this medical device is able to segment effectively healthy and tumor tissues and that it can correlate main semiological elements (identified thanks to the clinical and histopathological examinations) to the physico-optical characteristics obtained on the images of the medical device.

Official Title
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Interest of a New Medical Device for the Visualization of Cutaneous Lesions Based on Polarized Light

Conditions
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Skin Lesion

Intervention / Treatment
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* Device: Dermapol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patient with a skin tumor (benign or cancerous) which has to be excised and analysed according to histopathological examination skin lesion belonging to one of these groups (diagnosed by clinical examination): cutaneous cyst seborrhoeic keratosis cutaneous carcinoma naevus melanoma actinic keratosis and cutaneous horn other skin tumors skin lesion size equal to or less than 5 cm signed written consent form patient affiliated to a social insurance Exclusion Criteria: skin lesion size strictly over than 5 cm eyelid lesion aluminium, POM (polyoxymethylene) or organic glass allergy known pregnancy, breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermapol<br>Use of the experimental medical device | Device: Dermapol<br>* Use of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of lesions with semiological characteristics | Proportion of lesions for which at least one semiological characteristic (detected by the combination of visual and histopathological examinations) was identified by the medical device thanks to physico-optical properties | Before biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physico-optical description of the lesions | Physico-optical description of the cutaneous lesions by the medical device | Before biopsy | 
| Number of different semiological characteristics | Number of different semiological characteristics visualized by the medical device and by the combination of clinical and histopathological examinations for each image processing | Before biopsy | 
| Proportion of semiological characteristics properly identified | Proportion of semiological characteristics properly identified by the medical device for all lesions | Before biopsy | 
| Specificity, sensitivity and predictive values | Specificity, sensitivity, true positive rate, true negative rate, false positive rate, false negative rate of the medical device, for each semiological characteristic identified by the combination of the clinical and histopathological examinations | Before biopsy | 
| Cases proportion for which the same semiological characteristics list was found between the medical device and the combination of clinical and histopathological diagnosis | Proportion of cases with same semiological characteristics list | Before biopsy |