Interest of a New Medical Device for the Visualization of Cutaneous Lesions Based on Polarized Light
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Skin Lesion
- Sponsor
- University Hospital, Strasbourg, France
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Proportion of lesions with semiological characteristics
- Status
- Terminated
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Proportion of lesions with semiological characteristics
Time Frame: Before biopsy
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
Secondary Outcomes
- Number of different semiological characteristics(Before biopsy)
- Physico-optical description of the lesions(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(Before biopsy)
- Proportion of semiological characteristics properly identified(Before biopsy)
- Specificity, sensitivity and predictive values(Before biopsy)